FDA.reportPublic FDA data

BIG EASY, MASK

Primary DI
00850055775015
Brand
BIG EASY, MASK
Company
INNOVATION INSTITUTE, LLC
Model
33-90004
Published
2024-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055775015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055775015008500557750158500557750150850055775015

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
027184489
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055775008BIG EASY, NON-REBREATHING VALVE AND MASK33-900032024-10-30
00850055775022BIG EASY, NON-REBREATHING VALVE33-900052024-10-30
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
00850055775060Move-D Brace, Right3626-900012025-01-30
00850055775053Move-D Brace, Left3626-900152024-10-30
00860001704877Move-D3626-900012024-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118623681Endure IndustriesENDURE INDUSTRIESBSJ2026-08-14
06946430427496CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427519CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427533CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427557CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427571CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427595CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427618CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
14026704665010HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665188HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665218HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665225HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665232HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665249HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665256HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665263HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665270HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665041RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665065RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665072RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665089RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665096RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
10192253072037CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072044CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072051CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072068CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072075CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072082CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072105CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
04719874951085Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21