Identity
- Trade Name
- Thopaz+ FDA UDI
- Generic Name
- Thoracic suction pump FDA UDI
- Device Name
- Thoracic suction system pump 079.1002 FDA UDI
- Model / Reference
- Thopaz+ FDA UDI
- Description
- Thoracic suction system pump 079.1002 FDA UDI
Identifiers
- Catalog Number
- 200.5718 FDA UDI
- Primary DI / UDI-DI
- 07612367043298 FDA UDI
- 510(k) Number
- K141553 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Thoracic 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
MR Unsafe FDA UDI
Category: Thoracic suction pump
Thopaz+ by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic suction pump.
- Thoraguard — Centese, Inc. · Class II
- Passio Handheld Control Unit — BEARPAC MEDICAL, LLC · Class II
- ATMOS — ATMOS MedizinTechnik GmbH & Co. KG · Class II
- ATMOS — ATMOS MedizinTechnik GmbH & Co. KG · Class II
- Passio Pump Drainage System — BEARPAC MEDICAL, LLC · Class II
- Thopaz+ — Medela LLC · Class II
- Thopaz+ — Medela LLC · Class II
Cleared under the same submission
K141553 also covers:
- Docking Station — Medela LLC
- Docking Station Adapter for canister 2 L — Medela LLC
- Standard rail universal holder — Medela LLC
- Thopaz Tubing Extension, 1 Line, sterile — Medela LLC
- Thopaz Tubing Extension, 3 Lines, sterile — Medela LLC
- Thopaz disposable canister 0.3l — Medela LLC
- Thopaz disposable canister 0.8l — Medela LLC
- Thopaz disposable canister 2l — Medela LLC
- Thopaz disposable canister with 0.3l — Medela LLC
- Thopaz disposable canister with solidifier, 0.8l — Medela LLC
- Thopaz disposable canister with solidifier, 2l — Medela LLC
- Thopaz tubing double — 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 fb20dcd9-4b60-46e6-87a2-bfbb49ccb5e8 36 fields · synced May 30, 2026