Identity
- Trade Name
- Nisus Touch NPWT System FDA UDI
- Generic Name
- Negative-pressure wound therapy system pump, electric FDA UDI
- Device Name
- TCMPP-100 Nisus Touch NPWT System FDA UDI
- Model / Reference
- TCMPP-100 FDA UDI
- Description
- TCMPP-100 Nisus Touch NPWT System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851675007265 FDA UDI
- 510(k) Number
- K203693 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system pump, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Negative-pressure wound therapy system pump, electric
A comprehensive negative-pressure wound therapy system designed for the treatment of hard-to-heal open wounds, burns, diabetic/pressure ulcers, flaps and grafts. The device creates and controls negative pressure in a vacuum-assisted wound closure system using a computer-controlled vacuum pump with internal batteries.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cork Medical
Sources (1)
- FDA UDI 85f4387a-f7b6-4a37-b754-5f5fd738878c 34 fields · synced Jul 22, 2026