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Inline Sensor Assembly and Inline Temperature Sensor
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Inline Sensor Assembly and Inline Temperature Sensor FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Model / Reference
- INLINE TEMPERATURE SENSOR (ILS-1) FDA UDI
Identifiers
- Catalog Number
- CA-0001-001 FDA UDI
- Primary DI / UDI-DI
- 08886483507432 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
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
Category: Pulmonary artery balloon catheter, electrical
Inline Sensor Assembly and Inline Temperature Sensor by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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 140b8f2b-a421-4323-b253-0e7d195d4ee0 35 fields · synced Jun 1, 2026