Identity
- Trade Name
- Solventum US LLC FDA UDI
- Generic Name
- Negative-pressure wound therapy system dressing set FDA UDI
- Device Name
- Solventum™ Snap™ Plus Therapy Strap, STPASPEE, Small, 1/CS FDA UDI
- Model / Reference
- STPASPEE FDA UDI
- Description
- Solventum™ Snap™ Plus Therapy Strap, STPASPEE, Small, 1/CS FDA UDI
Identifiers
- Catalog Number
- STPASPEE FDA UDI
- Primary DI / UDI-DI
- 00197998028885 FDA UDI
- FDA Product Code
- OKO FDA UDI
- GMDN Term
- Negative-pressure wound therapy system dressing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4683 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy system dressing set
Solventum US LLC by Kci Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system dressing set.
- Advanced Series Hydrophobic Dressing Kit, Medium — Pensar Medical, LLC · Class II
- Nisus NPWT Wound Kit — Cork Medical · Class II
- 4L — 4L Health Co., Ltd. · Class II
- Kendall — Cardinal Health 200, LLC · Class II
- Advanced Series Combo Pack, Medium — Pensar Medical, LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- AVELLE — CONVATEC, PURCHASING DEPARTMENT · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kci Usa, Inc.
Sources (1)
- FDA UDI 6c3f95d6-91ca-4d39-83ba-6f11da5d6c05 35 fields · synced Jun 1, 2026