Identity
- Trade Name
- CoolFlow FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Model / Reference
- CFT001 FDA UDI
Identifiers
- Catalog Number
- CFT001 FDA UDI
- Primary DI / UDI-DI
- 10846835000016 FDA UDI
- PMA Number
- P990071 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Cardiac ablation system irrigation tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 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
No
FDA UDI
Category: Cardiac ablation system irrigation tubing set
CoolFlow by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac ablation system irrigation tubing set.
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- Cool Point™ — IRVINE BIOMEDICAL, INC. · Class III
- DiamondTemp™ Irrigation Tubing Set — MEDTRONIC, INC. · Class III
- AVANOS — Avanos Medical, Inc. · Class II
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class II
Cleared under the same submission
P990071 also covers:
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
- Biosense Webster Inc
Sources (1)
- FDA UDI 967ebd67-718e-4387-9580-db537b537665 36 fields · synced May 31, 2026