FDA.reportPublic FDA data

N/A

Primary DI
44710810119116
Brand
N/A
Company
GALEMED CORPORATION
Model
BR32
Catalog number
AN0082
Device description
nBag Resuscitator w/ Mask, #0
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112852000BABI PLUS NEONATAL RESUSCITATION BAGA Plus Medical2012-01-13BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810119116PackageGS112In Commercial Distribution
04710810119118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081011911644710810119116
04710810119118047108101191184710810119118

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656854379
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710810085550N/A71053AB01252026-03-05
24710810110171N/A5428AM00342026-03-05
24710810112458N/A5429AM00352026-03-05
04710810080586N/A3564AD00492026-03-05
04710810080838N/A5313AM00282026-03-05
04710810081781N/A5304AM00942026-03-05
04710810081811N/A5305AM00952026-03-05
04710810082122N/A3565AD00512026-03-05
04710810082252N/A5315AM00302026-03-05
04710810082269N/A5314AM00292026-03-05
04710810082405N/A5311AM00262026-03-05
04710810082412N/A5312AM00272026-03-05
04710810082429N/A5316AM00312026-03-05
04710810082481N/A5306AM00962026-03-05
04710810082962N/A3551AD00022026-03-05
04710810083327N/A74112AC00532026-03-05
04710810084621N/A2339AR00822026-03-05
04710810084669N/A2437AV00022026-03-05
04710810084850N/A75045AC01712026-03-05
04710810084942N/A0015AM00422026-03-05

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Primary DI, Brand, Company table
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