Identity
- Trade Name
- Thermodilution Catheter and Accessories FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Model / Reference
- TD2604NX (BNS)-CMS USA FDA UDI
Identifiers
- Catalog Number
- 21-000009-41 FDA UDI
- Primary DI / UDI-DI
- 08888893204758 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Ethylene Oxide FDA UDI
Thermodilution Catheter and Accessories by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 edd6791f-8497-433c-97c4-0eb1481cabe8 36 fields · synced May 30, 2026