Big Easy, Non-Rebreathing Valve And Mask

FDA UDI

Class I (US FDA UDI)

by Innovation Institute, Llc

Identity

Trade Name: BIG EASY, NON-REBREATHING VALVE AND MASK FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Model / Reference: 33-90003 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850055775008 FDA UDI
FDA Product Code: BSJ FDA UDI
CBP FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5550 FDA UDI
868.5870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary resuscitation mask, single-use Non-rebreathing valve, reusable

Big Easy, Non-Rebreathing Valve And Mask by Innovation Institute, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Innovation Institute, Llc

Sources (1)

FDA UDI 7941e526-76fb-4318-9c6a-b42cec5c2f57 32 fields · synced Jun 8, 2026