Identity
- Trade Name
- FERNO2 HFOC FDA UDI
- Generic Name
- Respiratory oxygen therapy system FDA UDI
- Device Name
- HFOC valve, refill valve for use with Bag Valve Mask resuscitator. FDA UDI
- Model / Reference
- T25301 FDA UDI
- Description
- HFOC valve, refill valve for use with Bag Valve Mask resuscitator. FDA UDI
Identifiers
- Catalog Number
- T25301 FDA UDI
- Primary DI / UDI-DI
- 00814940020185 FDA UDI
- 510(k) Number
- K953349 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Respiratory oxygen therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Respiratory oxygen therapy system
Ferno2 Hfoc by Spiracle Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen therapy system.
- 02-RESQ — Pulmodyne Inc. · Class II
- 02-RESQ — Pulmodyne Inc. · Class II
- GO-PAP — Pulmodyne Inc. · Class II
- O2-RESQ — Pulmodyne Inc. · Class II
- HI-OXYGEN MASK ADULT W/O VALVE, WITH 7FT TUBE, SINGLE PACKING — BESMED HEALTH BUSINESS CORP. · Class I
- O2-MAX — Pulmodyne Inc. · Class II
- Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
- AincA — Anesthesia Associates, Inc. · 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
- Spiracle Technology
Sources (1)
- FDA UDI 0e474fa1-e53f-4162-8d54-e42707c53c8d 35 fields · synced May 29, 2026