V.A.C.® GRANUFOAM™

Basic Information

• Brand Name: V.A.C.® GRANUFOAM™
• Primary DI: 00878237000762
• Version / Model: M8275075/5 M8275075/10
• Company Name: KCI USA, INC.
• Labeler DUNS: 102726734
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-13
• Public Version: 7
• Public Version Date: 2021-02-01
• Public Version Status: Update
• Public Device Record Key: a782c171-cc74-4324-9953-0552f4f5347c
• Distribution End Date: 2021-01-29

Device Description

Vac Granufoam Dressing Round Featuring Sensatrac Technology

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: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
47406	Negative-pressure wound therapy system foam dressing, non-antimicrobial	A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00878237000748	GS1	5 Pack	5	Not in Commercial Distribution	2021-01-29
Primary	00878237000762	GS1