FDA UDI
In Commercial Distribution
🇺🇸 United States
SNAP™
DI: 00849554006027
·
Model: SNPA125PLUS
·
KCI USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SNAP™
- Primary DI
- 00849554006027
- Version / Model
- SNPA125PLUS
- Company Name
- KCI USA, INC.
- Labeler DUNS
- 102726734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 5569f397-1fe1-43e7-8ca4-96d29e383c79
Device Description
Snap Therapy System Snap Plus 125mmHg Therapy Cartridge, 150ml
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 Unsafe
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | General, Plastic Surgery | 878.4683 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60884 | Negative-pressure wound therapy system pump, mechanical | A portable device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, venous/diabetic/pressure ulcers, surgical wounds, flaps and grafts. It creates a vacuum by non-electric mechanical means (e.g., spring) and is connected to a NPWT system dressing set. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849554006027 | GS1 | ||||
| Package | 20849554006021 | GS1 | 10 PACK | 10 | In Commercial Distribution | |
| Package | 00849554007093 | GS1 | 10 Pack | 10 | In Commercial Distribution |