FDA.reportPublic FDA data

Pocket Mask, SP (ARC)

Primary DI
07045430043701
Brand
Pocket Mask, SP (ARC)
Company
Laerdal Medical AS
Model
820015
Catalog number
820015
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
07045432068207PackageGS1100In Commercial Distribution
07045432119817PackageGS110In Commercial Distribution
07045430043701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07045432068207070454320682077045432068207
07045432119817070454321198177045432119817
07045430043701070454300437017045430043701

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 Temperature-40 Percent (%) Relative Humidity52 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity5 Degrees Celsius95 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius50 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
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
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
00628725099767PEDIATRIC THREE-IN-ONE MASKCanadian Hospital Specialties LimitedKGB2024-04-04
10840330704448ProCureTwin Med, LLCKGB2024-03-22
10840330704455ProCureTwin Med, LLCKGB2024-03-22
10840330704462ProCureTwin Med, LLCKGB2024-03-22
10840330704479ProCureTwin Med, LLCKGB2024-03-22
00628725096919Adult Oxygen MaskCanadian Hospital Specialties LimitedKGB2024-02-23
00628725096926Adult Oxygen Mask High ConcentrationCanadian Hospital Specialties LimitedKGB2024-02-23
00628725096933Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedKGB2024-02-23
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
10850049784747SURGYCOSurgyco LLCKGB2023-10-31
10850049784754SURGYCOSurgyco LLCKGB2023-10-31
10850049784761SURGYCOSurgyco LLCKGB2023-10-31
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00628725099798Pediatric High Concentration Oxygen MaskCanadian Hospital Specialties LimitedKGB2023-06-30
00628725099804Pediatric Three-In-One MaskCanadian Hospital Specialties LimitedKGB2023-06-30