FDA.report

BIG EASY, NON-REBREATHING VALVE AND MASK

Primary DI
00850055775008
Brand
BIG EASY, NON-REBREATHING VALVE AND MASK
Company
INNOVATION INSTITUTE, LLC
Model
33-90003
Published
2024-10-30
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850055775008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055775008008500557750088500557750080850055775008

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
027184489
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850055775060Move-D Brace, Right3626-900012025-01-30
00850055775015BIG EASY, MASK33-900042024-10-30
00850055775022BIG EASY, NON-REBREATHING VALVE33-900052024-10-30
00850055775053Move-D Brace, Left3626-900152024-10-30
00850055775084LiveBand BFR, Small Cuff3185-900082024-10-30
00850055775091LiveBand BFR, Medium Cuff3185-900092024-10-30
00850055775107LiveBand BFR, Large Cuff3185-900102024-10-30
00850055775114LiveBand BFR, Extra Large Cuff3185-900112024-10-30
00850055775077LiveBand BFR3185-900072024-10-29
00860001704877Move-D3626-900012024-10-29

Other Devices Sharing Product Codes

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50192253071441CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071458CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071465CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
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