Identity
- Trade Name
- C2 CryoBalloon Cartridge, Regular FDA UDI
- Generic Name
- High-pressure medical gas hose FDA UDI
- Device Name
- C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System FDA UDI
- Model / Reference
- FG-1010 FDA UDI
- Description
- C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System FDA UDI
Identifiers
- Catalog Number
- FG-1010 FDA UDI
- Primary DI / UDI-DI
- 00854924006101 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- High-pressure medical gas hose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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
Category: High-pressure medical gas hose
C2 CryoBalloon Cartridge, Regular by C2 Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as High-pressure medical gas hose.
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class I
- Tubing, Smooth Interior, Disposable, 22MM-60" — A-M Systems, Inc. · Class I
- Tubing, 1.125" I.D., 7/8"-7/8" Fittings, 34" L — A-M Systems, Inc. · Class I
- CO2 Hose and Yoke Shuttle Valve System — Northgate Technologies Inc. · Class II
- Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 34" L — A-M Systems, Inc. · Class I
- Quality Connect HD — DEHAS Medical Systems GmbH · Class I
- Tubing, Smooth Interior, Hytrel, IMC, 22MM-12" — A-M Systems, Inc. · Class I
- Tubing, Smooth Interior, Disposable, 1.375"-12" — A-M Systems, Inc. · Class I
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
- C2 Therapeutics, Inc.
Sources (1)
- FDA UDI 1d301c96-bcbd-44fd-8846-42dbc2880f12 35 fields · synced May 30, 2026