Item Healthcare Attributes

The following are the Item Healthcare attributes. You can set these attributes when you define or update items.

Attribute Group	Attribute Name	Description
Device Status	Combination Product	Indicates that the product contains two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device.
	HCT/P Product	Indicates that the product consists of human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3.
	Kit	Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products that are packaged together to achieve a common intended use.
FDA	Product Code	A unique code that identifies a specific product regulated by the U.S. Food and Drug Administration (FDA). It usually contains five to seven alphanumeric characters, with the most common type being a three-letter code for medical devices used for classification.
	Product Code Name	Name of the product associated with the product code.
	Product Physical State	Describes a device's physical characteristics, which helps determine its regulatory pathway, including premarket notification requirements.
	Device Class	Indicates the class assigned to the medical device. FDA regulates all medical devices marketed in the U.S. and assigns a class for each device. The class can be Class I, Class II, or Class III.
	Submission Type	Indicates a specific regulatory process used to submit a product for approval by the FDA.
GUDID Miscellaneous Attributes	Contains Natural Rubber Latex	Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Selecting Yes indicates that the device label or packaging contains one of the following statements: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. This Product Contains Dry Natural Rubber Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. The Packaging of This Product Contains Dry Natural Rubber.
	Not Made With Natural Rubber Latex	Indicates that natural rubber latex wasn’t used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437.
	Prescription Use	Indicates that the device requires a prescription to use.
	Over-the-Counter	Indicates that the device doesn’t require a prescription to use and can be purchased over the counter (OTC).
	What MRI Safety Information Does Labeling Contain?	Indicates the MRI Safety Information, if any, that’s present in the device labeling. See the ASTM F2503-13 standard for more information.
	Requires Sterilization?	Indicates that the device requires sterilization prior to use.
	Public Device Record Key	A unique key generated by the system to identify a device record, even if the primary DI changes.
	Public Version Number	A number generated by the system to track the public release updates to a device record.
	Public Version Date	Public release date of the device record.
	Public Version Status	The status of a device record associated with a record version change.
GUDID Package Device Identifiers	Package DI Number	A device identifier for the package configuration that contains multiple units of the base package (doesn’t include shipping containers).
	Package Discontinue Date	Indicates the date a particular package configuration is discontinued by the labeler.
	Package Status	Indicates whether the package configuration is available or discontinued: Package Discontinue Date > today or null, Package Status = In Commercial Distribution Package Discontinue Date =< today, Package Status = Not In Commercial Distribution
	Package Type	Type of packaging of the product (box, carton, and so on)
	Quantity Per Package	Number of packages contained within the particular package configuration with a unique DI.
	Contains DI Package	Package-level device identifier that's used to identify a package that contains one or more units of another device.
Healthcare Pricing Attributes	Chargeable	Indicates whether a patient can be charged for the inventory item.
	Charge Code	Charge code of the item.
	Charge Per Unit	Full price of the part including markups.
	Base Price:	Base price for the part excluding markups.
	Markup	Distributor markup for the item.
	Revenue Code:	Revenue code of the item.
Healthcare GUDID Primary	UDI Enabled	Indicates if the item is UDI enabled.
	Issuing Agency	Organization accredited by FDA to operate a system for the issuance of UDIs.
	Primary DI Number	Main identifier for a medical device and uniquely identifies a device through its distribution and use. The primary DI number will be located on the base package, which is the lowest package level of a medical device containing a full UDI. For medical devices without packaging, the primary DI number and full UDI may be on the device itself.
	Device Count	Number of medical devices in the base package. For example: Base Package =Box of 100 gloves; Primary DI = 101; Device Count =100
	Unit of Use DI Number	Identifier used by the hospital staff and materials management to account for a single device when the UDI is labeled on a higher level of packaging. The Unit of Use DI doesn’t appear on the label.
	Labeler D-U-N-S Number	Identifies the labeler for a version or model of a device. Business number issued by Dun & Bradstreet (D&B) that’s used to associate the labeler (company) name and address to a given version of model of a device in GUDID.
	Company Name	Company’s name associated with the labeler DUNS number entered in the DI record.
	Company Address:	Company’s physical address associated with the labeler DUNS number entered in the DI record.
	Brand Name	The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. This is recognizable by the consumer. This name is typically registered with USPTO and have the ® and/or TM symbol. This information may: Be on a label attached to a durable device Be on a package of a disposable device Appear in labeling materials of an implantable device
	Device Version	The version or model found on the device label or accompanying packaging used to identify a category or design of a device.
	Catalog Number	The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product.
	Device Description	Additional relevant information about the device that’s not already captured as a distinct GUDID data attribute.
	Device Exempt From Premarket Submission	Device is exempt from FDA Premarket regulations; or a preamendment device.
	FDA Listing Number	Number assigned by FDA during registration and listing to all devices in commercial distribution, regardless of pre-market authorization requirements per 21 CFR 807.28(f).
	For Single-use	Indicates that the device is intended for one use or on a single patient during a single procedure.
Healthcare Standardized Codes	UNSPSC	The United Nations Standard Products and Services Code® (UNSPSC®) is a global classification system of products and services. These codes are used to classify products and services.
	UNSPSC Segment	UNSPSC segment of the item.
	UNSPSC Family	UNSPSC family of the item.
	UNSPSC Class:	UNSPSC class of the item.
	UNSPSC Commodity:	UNSPSC commodity of the item.
	HCPCS	The Healthcare Common Procedure Coding System (HCPCS) code of the item. It’s a collection of standard codes for medical procedures, supplies, products, and services. The codes help to process health insurance claims by insurers.
	HCPCS Description:	HCPCS description of the item.
	HCPCS Status:	HCPCS status of the item.
Healthcare Additional Attributes	Implantable	Indicates whether the part can be implanted.
	Implant Type	Category of the medical device that involve implanting a device or material into the body to support, enhance, or replace functions.
	Color	Color of the item.
	Latex Product	Indicates if the item contains latex.
	Sterility	Sterility of the item.
	Breakable Pack?	Indicates if the item can only be used in a pack and not individually.
	Clinical	Indicates whether the item is clinical.
	Surgical Instrument	Indicates whether the medical device is used during surgery.
	Reprocessed	Indicates whether the medical device is reprocessed.
	No. Of Usages	Number of times the medical device can be used.
GUDID Sterilization Method	Sterilization Methods	Indicates the method(s) of sterilization that can be used for this device.