Identity
- Trade Name
- Ambulating Bulb FDA UDI
- Generic Name
- Whole-blood-recovery autotransfusion system, manual FDA UDI
- Device Name
- Ambulating Bulb FDA UDI
- Model / Reference
- 225-028-852 FDA UDI
- Description
- Ambulating Bulb FDA UDI
Identifiers
- Catalog Number
- 225-028-852 FDA UDI
- Primary DI / UDI-DI
- 00855168008579 FDA UDI
- 510(k) Number
- K970714 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Whole-blood-recovery autotransfusion system, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5830 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: Whole-blood-recovery autotransfusion system, manual
Ambulating Bulb by 3T Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K970714 also covers:
- CBCII ConstaVac — 3T Medical Systems Inc.
- CBCII ConstaVac — 3T Medical Systems Inc.
- CBCII ConstaVac — 3T Medical Systems Inc.
- CBCII ConstaVac — 3T Medical Systems Inc.
- ConstaVac CBC II — 3T Medical Systems Inc.
- ConstaVac CBC II — 3T Medical Systems Inc.
- ConstaVac CBC II — 3T Medical Systems Inc.
- Constavac CBC II — 3T Medical Systems Inc.
- Constavac CBC II — 3T Medical Systems Inc.
- Constavac CBC II — 3T Medical Systems Inc.
- Constavac CBC III — 3T Medical Systems Inc.
- Constavac CBC III — 3T Medical Systems Inc.
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
- 3T Medical Systems Inc.
Sources (1)
- FDA UDI 5c6b6603-3c53-4f57-97f4-96dbc4fe2886 36 fields · synced Jun 1, 2026