Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Surgical suction pump FDA UDI
- Model / Reference
- TC-C4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019778006505 FDA UDI
- FDA Product Code
- FEM FDA UDI
- GMDN Term
- Surgical suction pump FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
No
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
Yes
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
Olympus by Keymed (Medical & Industrial Equipment), Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical suction pump.
- Dominant Flex portable — Medela LLC · Class II
- KV-6 Suction Pump — Medela LLC · Class II
- Wells Johnson Elite Infiltrator/Aspirator — The Wells Johnson Company · Class II
- Wells Johnson Elite Infiltrator/Aspirator — The Wells Johnson Company · Class II
- Given Vario Pump Kit — Medela LLC · Class II
- Vario 18 AC/DC — Medela LLC · Class II
- Rocket — Rocket Medical Plc · Class II
- Basic portable — Medela LLC · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keymed (Medical & Industrial Equipment), Ltd.
Sources (1)
- FDA UDI e091ffd8-ef25-42e5-9f2c-789a811fc2d7 32 fields · synced May 30, 2026