FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Series Hydrophobic Dressing Kit, Small
DI: 10851978007259
·
Model: 8463540 0731
·
Pensar Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Advanced Series Hydrophobic Dressing Kit, Small
- Primary DI
- 10851978007259
- Version / Model
- 8463540 0731
- Company Name
- Pensar Medical, LLC
- Labeler DUNS
- 079262228
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-10-07
- Public Version
- 1
- Public Version Date
- 2022-10-17
- Public Version Status
- New
- Public Device Record Key
- 399d9e50-df20-4aa9-b1bb-60cd2a8d1570
Device Description
Advanced Series Hydrophobic Dressing Kit, Small, 10 per case
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 47956 | Negative-pressure wound therapy system dressing set | A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00851978007252 | GS1 | ||||
| Primary | 10851978007259 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150960 | 000 |