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Docking Station Adapter for canister 2 L
FDA UDIClass II (US FDA UDI)
by Medela LLC
Identity
- Trade Name
- Docking Station Adapter for canister 2 L FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Device Name
- Adapter to docking station for Thopaz canister 2L FDA UDI
- Model / Reference
- 079.0038 FDA UDI
- Description
- Adapter to docking station for Thopaz canister 2L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367025133 FDA UDI
- 510(k) Number
- K141553 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Noninvasive device battery charger 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Noninvasive device battery charger
Docking Station Adapter for canister 2 L by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Noninvasive device battery charger.
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Cleared under the same submission
K141553 also covers:
- Docking Station — 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
- Thopaz tubing double, large connector — 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 22c2a323-e03e-46f5-8b4f-5e996030c4c3 35 fields · synced May 31, 2026