Identity
- Trade Name
- SMARTFREEZE™ FDA UDI
- Generic Name
- Liquid nitrous oxide coaxial tubing FDA UDI
- Device Name
- Cryo-Cable FDA UDI
- Model / Reference
- M004CRBS5210 FDA UDI
- Description
- Cryo-Cable FDA UDI
Identifiers
- Catalog Number
- M004CRBS5210 FDA UDI
- Primary DI / UDI-DI
- 00191506039684 FDA UDI
- PMA Number
- P220032 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Liquid nitrous oxide coaxial tubing FDA UDI
Classification
- Device Class
- Class III 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: Liquid nitrous oxide coaxial tubing
Smartfreeze™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Liquid nitrous oxide coaxial tubing.
- Epimed — EPIMED INTERNATIONAL, INC. · Class II
Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI fe927f12-b7b6-44e2-96c6-88c6d0dbe5c1 35 fields · synced Jun 1, 2026