Identity
- Trade Name
- Thermodilution Catheter and Accessories FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Model / Reference
- TD1604ND-ARG(497537) FDA UDI
Identifiers
- Catalog Number
- 21-000138-01 FDA UDI
- Primary DI / UDI-DI
- 08886483501348 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Pulmonary artery balloon catheter, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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: Pulmonary artery balloon catheter, electrical
Thermodilution Catheter and Accessories by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bioptimal International Pte. Ltd.
Sources (1)
- FDA UDI 8ce21d3b-9d37-419d-9b1f-2d4a1b8f29c9 34 fields · synced May 30, 2026