FDA.reportPublic FDA data

Anest mask reuse,size 4 with MAQUET

Primary DI
17325710002046
Brand
Anest mask reuse,size 4 with MAQUET
Company
Maquet Critical Care AB
Model
6694577
Published
2015-10-30
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
false

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
17325710002046PackageGS110In Commercial Distribution
07325710002049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1732571000204617325710002046
07325710002049073257100020497325710002049

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
632707092
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
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07325710000632Adap etCO2 Airway Neo47217882015-10-22
07325710004180CAPNOSTAT 568820782016-01-27
07325710009796CO2 ANALYZER MODULE CAPNOSTAT 568870502018-10-09
27325710011144ITS HousingPV404668827732026-03-24
27325710011601PiCCO catheterPV2015L2068850492026-03-24
27325710017047PiCCO catheterPV2013L0768850442026-03-24
27325710017061PiCCO catheterPV2014L1668850462026-03-24
27325710017092PiCCO catheterPV2014L0868850452026-03-24
27325710017108PiCCO catheterPV2014L2268850472026-03-24
07325710011140ITS HousingPV404668827732026-03-24
07325710011607PiCCO catheterPV2015L2068850492026-03-24
07325710017043PiCCO catheterPV2013L0768850442026-03-24
07325710017067PiCCO catheterPV2014L1668850462026-03-24
07325710017098PiCCO catheterPV2014L0868850452026-03-24
07325710017104PiCCO catheterPV2014L2268850472026-03-24
07325710012642Battery module68890002025-01-19
07325710001318FLOW-i C4066774002015-10-22
07325710001349FLOW-i C2066772002015-10-18
07325710001363FLOW-i C3066773002015-10-18
07325710012673Drawer for Low mobile carts68903652023-12-10

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Primary DI, Brand, Company table
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