CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380097669
• Version / Model: 47-7000
• Catalog Number: 47-7000
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-12
• Public Version: 7
• Public Version Date: 2021-08-03
• Public Version Status: Update
• Public Device Record Key: 03555cb3-d756-40c7-9d2a-d50b023711a3
• Distribution End Date: 2021-08-02

Device Description

NPWT Polyurethane Drape

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	negative pressure wound therapy Powered suction pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47405	Negative-pressure wound therapy system drape	A sheet of plastic material designed to be placed over a wound dressing (e.g. open-cell foam or medicated gauze) to create a complete occlusion over and around a wound during negative pressure wound therapy (NPWT). This film dressing is typically vapour permeable, waterproof, and has an adhesive backing or edges applied against the wound dressing and surrounding healthy skin to create an airtight seal; it may be impregnated/coated with a gel (e.g., silicone) to minimize risk of trauma upon removal. It has a central opening, or an opening is made in or under it, to enable placement of the drain allowing negative pressure to reach the wound through the dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885380097669	GS1
Package	50885380097667	GS1	CASE	10	Not in Commercial Distribution	2021-08-02

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius