Identity
- Trade Name
- Thopaz tubing double FDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Double Tubing with large connector for thoracic suction system pump FDA UDI
- Model / Reference
- 079.0022 FDA UDI
- Description
- Double Tubing with large connector for thoracic suction system pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367014229 FDA UDI
- 510(k) Number
- K141553 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Suction/irrigation tubing, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suction/irrigation tubing, single-use
Thopaz tubing double by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
- Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
- AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
- Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
- Bioseal Inc. — BIOSEAL · Class I
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, 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 a4246a67-33f5-43e2-9873-7bd1a675335d 35 fields · synced May 30, 2026