FDA.report

The BAG II Resuscitator Infant w/mask #1

Primary DI
07045432067958
Brand
The BAG II Resuscitator Infant w/mask #1
Company
Laerdal Medical AS
Model
845131
Catalog number
845131
Device description
The BAG II are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport.
Published
2015-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07045432068016PackageGS112In Commercial Distribution
07045432067958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07045432068016070454320680167045432068016
07045432067958070454320679587045432067958

GMDN Terms

TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(800)4311055customerservice@laerdal.com

Regulatory Flags

DUNS number
730624095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
07045432115987The BAG Mask size 18470111 8470111 2026-01-14
07045432115994The BAG Mask size 2 847012184701212026-01-14
07045432116007The BAG Mask size 3 8470128470122026-01-14
07045432116014The BAG Mask size 484701412026-01-14
07045432116021The BAG Mask size 5847015184701512026-01-14
07045432116083The BAG PEEP Valve 2-10 cmH2O847021184702112026-01-14
07045432116090The BAG PEEP Valve 5-20 cmH2O8470211 8470211 2026-01-14
07045432116144The BAG Manometer8470401 8470401 2026-01-14
07045432118179Pocket Mask, PB (DE FR ES IT EN)82002133820021332025-08-27
07045432118285Pocket Mask, SP Blue (DE FR ES IT EN)82002133820021332025-08-27
07045432119244Pocket Mask, HC Yellow (DE FR ES IT EN)82002133820021332025-08-27
07045432118186Pocket Mask, PB (EN)82000133820001332025-08-25
07045432118230Pocket Mask, SP Blue (EN)82002133820021332025-08-25
07045432119282Pocket Mask, HC White Private Label8299328299322025-08-25
07045432119305Pocket Mask, SP Black Private Label8299228299222025-08-25

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