FDA UDI
Not in Commercial Distribution
🇺🇸 United States
V.A.C.®
DI: 00849554002562
·
Model: M8275080/5
·
KCI USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- V.A.C.®
- Primary DI
- 00849554002562
- Version / Model
- M8275080/5
- Company Name
- KCI USA, INC.
- Labeler DUNS
- 102726734
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 5
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- b4a1da48-cb07-4f6a-b5b2-7ccd900cf363
- Distribution End Date
- 2018-06-08
Device Description
Vac Abdominal Dressing 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 |
|---|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61147 | Negative-pressure wound therapy open-abdomen dressing | A sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849554002562 | GS1 | ||||
| Package | 00878237001424 | GS1 | 5 PACK | 5 | Not in Commercial Distribution | 2018-06-08 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022011 | 000 |