Identity
- Trade Name
- CRITICATH™ SP5107H-14 TD CATHETER FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Device Name
- Heparin coated catheter 7 Fr, 4 Lumen with tube 110cm FDA UDI
- Model / Reference
- 680088 FDA UDI
- Description
- Heparin coated catheter 7 Fr, 4 Lumen with tube 110cm FDA UDI
Identifiers
- Catalog Number
- 680088 FDA UDI
- Primary DI / UDI-DI
- 00886333600885 FDA UDI
- FDA Product Code
- KRB FDA UDI
- GMDN Term
- Pulmonary artery balloon catheter, electrical 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
Yes
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: Pulmonary artery balloon catheter, electrical
Criticath™ Sp5107h-14 Td Catheter by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary artery balloon catheter, electrical.
- ARROW — TELEFLEX INCORPORATED · Class II
- SWAN-GANZ VIP — Edwards Lifesciences LLC · Class II
- SWAN-GANZ CONTROLCATH TRUE SIZE — Edwards Lifesciences LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Thermodilution Catheter and Accessories — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 379221e3-7270-40c8-b84d-cd70f0491925 36 fields · synced Jun 6, 2026