FDA UDI
In Commercial Distribution
🇺🇸 United States
V.A.C.® GRANUFOAM™ Silver™
DI: 00849554002494
·
Model: M8275096/5 M8275096/10
·
KCI USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- V.A.C.® GRANUFOAM™ Silver™
- Primary DI
- 00849554002494
- Version / Model
- M8275096/5 M8275096/10
- Company Name
- KCI USA, INC.
- Labeler DUNS
- 102726734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 4
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 32bc0dbb-57ed-48b2-9141-d8dd26fb862a
Device Description
Vac Granufoam Silver Dressing Medium 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 |
|---|---|---|---|---|
| 47407 | Negative-pressure wound therapy system foam dressing, 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), and that contains an antimicrobial agent [e.g., silver (Ag)]. 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 |
|---|---|---|---|---|---|---|
| Primary | 00849554002494 | GS1 | ||||
| Package | 00849554000896 | GS1 | 5 PACK | 5 | In Commercial Distribution | |
| Package | 00849554000902 | GS1 | 10 PACK | 10 | In Commercial Distribution |