FDA.reportPublic FDA data

N/A

Primary DI
44710810086449
Brand
N/A
Company
GALEMED CORPORATION
Model
5303
Catalog number
AM0093
Device description
Airsoft Mask, #2
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
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810086449PackageGS150In Commercial Distribution
04710810086441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081008644944710810086449
04710810086441047108100864414710810086441

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656854379
Device count
1
DM exempt
false
Premarket exempt
true
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
Primary DIBrandCompanyProduct codePublished
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14026704665188HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665218HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665225HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665232HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665249HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665256HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665263HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665270HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665041RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665065RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665072RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665089RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665096RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
10192253072037CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072044CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072051CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072068CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072075CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072082CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072105CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
04719874951085Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
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04719874958664Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
14026704664983HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704664990HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665003HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665027HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24