Identity
- Trade Name
- Vacuson 60 FDA UDI
- Generic Name
- Surgical suction pump FDA UDI
- Device Name
- Surgical suction pump FDA UDI
- Model / Reference
- 4280-115 FDA UDI
- Description
- Surgical suction pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- ENOU42801150 FDA UDI
- 510(k) Number
- K042943 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Surgical suction pump 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
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical suction pump
Vacuson 60 by Nouvag AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Given Vario Pump Kit — Medela LLC · Class II
- Vario 18 AC/DC — Medela LLC · Class II
- Olumpus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
Cleared under the same submission
K042943 also covers:
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
- Nouvag AG
Sources (1)
- FDA UDI 0a91979f-5ba1-4402-a260-6bee8557a7d8 35 fields · synced Jun 6, 2026