Identity
- Trade Name
- CRITIKIT(TM) SP4500 FDA UDI
- Generic Name
- Thermal-dilution cardiac output unit FDA UDI
- Device Name
- CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing and a 2-way check valve. It has a 10ml control syringe and a separate packed 3-way stopcock and 2 protective caps. FDA UDI
- Model / Reference
- 680000 FDA UDI
- Description
- CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing and a 2-way check valve. It has a 10ml control syringe and a separate packed 3-way stopcock and 2 protective caps. FDA UDI
Identifiers
- Catalog Number
- 680000 FDA UDI
- Primary DI / UDI-DI
- 00886333600007 FDA UDI
- FDA Product Code
- KRB FDA UDI
- GMDN Term
- Thermal-dilution cardiac output unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1915 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
Yes
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
No
FDA UDI
Category: Thermal-dilution cardiac output unit
Critikit(tm) Sp4500 by Argon Critical Care Systems Singapore 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
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI e7aa6ddf-1738-447a-b979-36b8bc365958 36 fields · synced Jun 8, 2026