Identity
- Trade Name
- Tubing set FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Tubing set for infiltration FDA UDI
- Model / Reference
- 6022EXC FDA UDI
- Description
- Tubing set for infiltration FDA UDI
Identifiers
- Primary DI / UDI-DI
- ENOU6022EXC9 FDA UDI
- 510(k) Number
- K071588 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tubing set by Nouvag AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K071588 also covers:
- ClosureFast — Covidien LP
- ClosureFast — Covidien LP
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 LipoPlus — Nouvag AG
- Dispenser DP 30 LipoPlus — Nouvag AG
- Dispenser DP 30 LipoPlus — Nouvag AG
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 |
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Manufacturer
- Manufacturer
- Nouvag AG
Sources (1)
- FDA UDI d0101eed-63fd-4325-8e98-cb097f42f3d0 36 fields · synced May 31, 2026