Identity
- Trade Name
- Epimed FDA UDI
- Generic Name
- Liquid nitrous oxide coaxial tubing FDA UDI
- Device Name
- PainBlocker™ Console Exhaust Tubing FDA UDI
- Model / Reference
- 412-CCET FDA UDI
- Description
- PainBlocker™ Console Exhaust Tubing FDA UDI
Identifiers
- Catalog Number
- 412-CCET FDA UDI
- Primary DI / UDI-DI
- 00818788021908 FDA UDI
- FDA Product Code
- GXH FDA UDI
- GMDN Term
- Liquid nitrous oxide coaxial tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Liquid nitrous oxide coaxial tubing
Epimed by Epimed International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Liquid nitrous oxide coaxial tubing.
- SMARTFREEZE™ — Boston Scientific · Class III
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
- Epimed International, Inc.
Sources (1)
- FDA UDI e5b3ed45-9689-4e1b-b97a-050c0ef6123a 36 fields · synced Jun 4, 2026