Identity
- Trade Name
- Thopaz FDA UDI
- Generic Name
- Thoracic suction pump FDA UDI
- Device Name
- Thoracic suction system pump 079.0002 FDA UDI
- Model / Reference
- Thopaz FDA UDI
- Description
- Thoracic suction system pump 079.0002 FDA UDI
Identifiers
- Catalog Number
- 200.2219 FDA UDI
- Primary DI / UDI-DI
- 07612367017480 FDA UDI
- 510(k) Number
- K130210 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
- Not 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
Thopaz by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K130210 also covers:
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 c704fe5a-aa23-4d52-a69a-69e3210f8363 37 fields · synced May 31, 2026