FDA UDI
In Commercial Distribution
🇺🇸 United States
Solventum US LLC
DI: 00197998028878
·
Model: STPASEE
·
KCI USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solventum US LLC
- Primary DI
- 00197998028878
- Version / Model
- STPASEE
- Catalog Number
- STPASEE
- Company Name
- KCI USA, INC.
- Labeler DUNS
- 102726734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-23
- Public Version
- 1
- Public Version Date
- 2025-07-31
- Public Version Status
- New
- Public Device Record Key
- c25d275d-9ac3-4e2b-bccc-174ee286f5d0
Device Description
Solventum™ Snap™ Therapy Strap, STPASEE, Small, 1/CS
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00197998028878 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]