FDA.reportPublic FDA data

Pocket Mask w/gloves ARC stock no.329705

Primary DI
07045430043688
Brand
Pocket Mask w/gloves ARC stock no.329705
Company
Laerdal Medical AS
Model
820012
Catalog number
820012
Device description
The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07045432068191PackageGS1100In Commercial Distribution
07045432119800PackageGS110In Commercial Distribution
07045430043688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07045432068191070454320681917045432068191
07045432119800070454321198007045432119800
07045430043688070454300436887045430043688

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
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius
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
04719874950989Create BiotechCREATE BIOTECH CO., LTD.KGB2026-07-21
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10197344009602HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344009619HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011476HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011483HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011506HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011810HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344042180HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
00840117345232Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345249Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345256Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345263Resp-O2 O2 Non-Rebreather Standard MaskDynarex CorporationKGB2025-05-30
00840117345270Resp-O2 O2 3-in-1 Elongated MaskDynarex CorporationKGB2025-05-30
00840117345225Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-29
10889483570562AirLife™AIRLIFECBP2025-03-28
10889483569238AirLife™AIRLIFEKGB2025-02-19
00026072023365BFAllied Medical, LLCKGB2024-10-11
00628725095547Face mask - PediatricCanadian Hospital Specialties LimitedKGB2024-05-16
00628725096971Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedKGB2024-04-22
00840118608060ENDURE INDUSTRIESENDURE INDUSTRIESKGB2024-04-10
00840118611619ENDURE INDUSTRIESENDURE INDUSTRIESKGB2024-04-10
00628725099767PEDIATRIC THREE-IN-ONE MASKCanadian Hospital Specialties LimitedKGB2024-04-04
00840118608046ENDURE INDUSTRIESENDURE INDUSTRIESKGB2024-04-01
00840118611633ENDURE INDUSTRIESENDURE INDUSTRIESKGB2024-04-01
10840330704448ProCureTwin Med, LLCKGB2024-03-22
10840330704455ProCureTwin Med, LLCKGB2024-03-22