Identity
- Trade Name
- Safety device plugged into pump FDA UDI
- Generic Name
- Surgical suction system collection container, reusable FDA UDI
- Device Name
- Safety set for Basic and Dominat Flex as well as Basic 30 and Dominant 50 FDA UDI
- Model / Reference
- 077.0711 FDA UDI
- Description
- Safety set for Basic and Dominat Flex as well as Basic 30 and Dominant 50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367004138 FDA UDI
- FDA Product Code
- BTA FDA UDIQPB FDA UDI
- GMDN Term
- Surgical suction system collection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical suction system collection container, reusable
Safety device plugged into pump by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 portable — 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
K150134 also covers:
- Angle piece Orange DCS — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic portable — 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
K170329 also covers:
- Angle piece Orange DCS — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic portable — 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
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
- Medela LLC
Sources (1)
- FDA UDI 78f92458-e8a7-4aaa-b683-bc4edbd11a7b 35 fields · synced Jun 6, 2026