FDA.reportPublic FDA data

LIFE®CPR Mask

Primary DI
B188LIFE100B0
Brand
LIFE®CPR Mask
Company
Mv Life LLC
Model
LIFE-100-B
Device description
LIFE®CPR Mask with one-way valve in nylon zip bag.
Published
2016-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010191000Y2000 POCKET RESCUECheen Houng Ent. Co. , Ltd.2001-03-14CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B188LIFE100B0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-800-700-0202Email@LIFEcorporation.com

Regulatory Flags#

DUNS number
096584064
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B188LIFE0250LIFE®OxygenPacLIFE-0252016-06-29
B188LIFE025REG0LIFE®RegulatorLIFE-025 Regulator2016-06-29
B188LIFE1000LIFE®CPR MaskLIFE-1002016-06-29
B188LIFE1010LIFE®CylinderLIFE-1012016-06-29
B188LIFE1020LIFE®CPR MaskLIFE-1022016-06-29
B188LIFE20250LIFE®SoftPacLIFE-2-0252016-06-29
B188LIFE21010LIFE®CylinderLIFE-2-1012016-06-29
B188LIFE26120LIFE®SoftPacLIFE-2-6122016-06-29
B188LIFE26FF0LIFE®SoftPacLIFE-2-6FF2016-06-29
B188LIFE6120LIFE®OxygenPacLIFE-6122016-06-29
B188LIFE612REG0LIFE®RegulatorLIFE-612 Regulator2016-06-29
B188LIFE6FF0LIFE®OxygenPacLIFE-6FF2016-06-29
B188LIFE6FFREG0LIFE®RegulatorLIFE-6FF Regulator2016-06-29
B188LIFEEMS02510LIFE®RegulatorLIFE-EMS-025-12016-06-29
B188LIFEEMS02530LIFE®RegulatorLIFE-EMS-025-32016-06-29
B188LIFEEMSD0LIFE®CylinderLIFE-EMS-D2016-06-29
B188LIFEEMSE0LIFE®CylinderLIFE-EMS-E2016-06-29
B188LIFEO21010LIFE®CylinderLIFE-O2-1012016-06-29
B188LIFEO2LSS0LIFE®StartSystemLIFE-O2-LSS2016-06-29
00860009971103OxyHome1400-51002023-03-28

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Primary DI, Brand, Company table
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09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
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