FDA.reportPublic FDA data

Pocket Mask HC PL no logo large

Primary DI
07045430011519
Brand
Pocket Mask HC PL no logo large
Company
Laerdal Medical AS
Model
820032
Catalog number
820032
Device description
The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant.
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07045432068221PackageGS1100In Commercial Distribution
07045430011519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07045432068221070454320682217045432068221
07045430011519070454300115197045430011519

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, reusableA 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). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius52 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)4311055customerservice@laerdal.com
(877) 523-7325customerservice@laerdal.com

Regulatory Flags#

DUNS number
730624095
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07045432119350The BAG™ Resuscitator - Newborn model847110401 2026-03-30
07045432119398The BAG™ Resuscitator - Pediatric model8472304012026-03-30
07045432119411The BAG™ Resuscitator - Adult model847340401 2026-03-30
07045432119503The BAG™ Resuscitator - Adult model847350401 2026-03-30
07045432119534The BAG™ Resuscitator - Pediatric model847220401 2026-03-30
07045432120462Laerdal Silicone Masks851500-12026-01-29
07045432120479Laerdal Silicone Masks851600-12026-01-29
07045432120486Laerdal Silicone Masks851700-1 2026-01-29
07045432120493Laerdal Silicone Masks860220-12026-01-29
07045432120509Laerdal Silicone Masks870220-12026-01-29
07045432116038The BAG Mask size 18470111 8470111 2026-01-14
07045432116045The BAG Mask size 2 847012184701212026-01-14
07045432116052The BAG Mask size 3 8470128470122026-01-14
07045432116069The BAG Mask size 484701412026-01-14
07045432116076The BAG Mask size 5847015184701512026-01-14
07045432116106The BAG PEEP Valve 2-10 cmH2O847021184702112026-01-14
07045432116113The BAG PEEP Valve 5-20 cmH2O8470211 8470211 2026-01-14
07045432116151The BAG Manometer8470401 8470401 2026-01-14
07045432115987The BAG Mask size 18470111 8470111 2026-01-14
07045432115994The BAG Mask size 2 847012184701212026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
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
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
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0076658806057625M - First Aid Kit - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
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0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813058316PW - Los Alamos - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658814080310PW - RJ Corman - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15