Identity
- Trade Name
- BIG EASY, NON-REBREATHING VALVE FDA UDI
- Generic Name
- Non-rebreathing valve, reusable FDA UDI
- Model / Reference
- 33-90005 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850055775022 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Non-rebreathing valve, reusable 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-rebreathing valve, reusable
Big Easy, Non-Rebreathing Valve by Innovation Institute, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rebreathing valve, reusable.
- AincA — Anesthesia Associates, Inc. · Class II
- RESMED — RESMED PTY LTD · Class II
- BE 30-115-B Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- KIT-BAG TEE/SCAV SWIVEL ASSY — Parker Hannifin Corp. · Class I
- BE 30-115-BL Low Resistance Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- BE 131 One-Way Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- BE 117 Non-Rebreathing Tee Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- Disposable Exp. Valve Carina — Drägerwerk AG & Co. KGaA · 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
- Innovation Institute, Llc
Sources (1)
- FDA UDI e6d988f8-f9cc-44cc-a790-6e786584ef36 32 fields · synced May 31, 2026