Identity
- Trade Name
- Basic portable FDA UDI
- Generic Name
- Surgical suction pump FDA UDI
- Device Name
- Powered suction pump 071.0000 FDA UDI
- Model / Reference
- Basic FDA UDI
- Description
- Powered suction pump 071.0000 FDA UDI
Identifiers
- Catalog Number
- 200.5461 FDA UDI
- Primary DI / UDI-DI
- 07612367039604 FDA UDI
- FDA Product Code
- BTA FDA UDIHDB FDA UDIMUU FDA UDIQPB FDA UDI
- GMDN Term
- Surgical suction pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI884.4340 FDA UDI878.5040 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
MR Unsafe FDA UDI
Category: Surgical suction pump
Basic portable by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical suction pump.
- Wells Johnson Elite Infiltrator/Aspirator — The Wells Johnson Company · Class II
- Wells Johnson Elite Infiltrator/Aspirator — The Wells Johnson Company · Class II
- Olumpus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
- Rocket — Rocket Medical Plc · Class II
- Vacuson 60 — Nouvag AG · Class II
- RenovaRP — GI Supply, Inc. · Class II
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
Cleared under the same submission
K130123 also covers:
- Angle piece — Medela LLC
- Angle piece — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic rack — Medela LLC
- Change-over valve with clampholder and tubing set — Medela LLC
- Clamp holder, plastic — Medela LLC
- Diposable virus / odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria Odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria filter — Medela LLC
- Disposable Overflow Protection / Virus Filter — Medela LLC
K150134 also covers:
- Angle piece Orange DCS — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic rack — Medela LLC
- Disposable tubing — Medela LLC
- Dominant Flex — Medela LLC
- Dominant Flex — Medela LLC
- Dominant Flex portable — Medela LLC
- Dominant Flex rack — Medela LLC
- Foot ON/OFF switch for Basic/Dominant — Medela LLC
- Foot vacuum regulator — Medela LLC
K170329 also covers:
- Angle piece Orange DCS — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic rack — Medela LLC
- Disposable tubing — Medela LLC
- Dominant Flex — Medela LLC
- Dominant Flex — Medela LLC
- Dominant Flex portable — Medela LLC
- Dominant Flex rack — Medela LLC
- Foot ON/OFF switch for Basic/Dominant — Medela LLC
- Foot vacuum regulator — Medela LLC
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
- Medela LLC
Sources (1)
- FDA UDI 5f53140c-1337-4d03-a1aa-b5df55d39e9e 36 fields · synced Jun 6, 2026