FDA.reportPublic FDA data

Anesthesia mask disp, size 3

Primary DI
17325710002435
Brand
Anesthesia mask disp, size 3
Company
Maquet Critical Care AB
Model
6694262
Published
2015-12-10
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

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
17325710002435PackageGS120In Commercial Distribution
07325710002438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1732571000243517325710002435
07325710002438073257100024387325710002438

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
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

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07325710017043PiCCO catheterPV2013L0768850442026-03-24
07325710017067PiCCO catheterPV2014L1668850462026-03-24
07325710017098PiCCO catheterPV2014L0868850452026-03-24
07325710017104PiCCO catheterPV2014L2268850472026-03-24
07325710012673Drawer for Low mobile carts68903652023-12-10
07325710001653Compressor Mini 115V 60Hz64817792023-09-21
07325710015117Servo-air Lite68932002023-09-21
07325710010518Base Unit Servo-u MR68888002021-12-01
07325710012185Heliox Servo adapter kit68894872021-06-18
07325710001189Air inlet filter68824082020-09-16
07325710003114Base unit, Servo-air68820002020-09-16
07325710003909Battery module68826072020-09-16
07325710004159Mobile Cart, Flat Pack Servo-air68819992020-09-16
07325710004166Shelf base, Servo-air68820022020-09-16
07325710004210Support arm 17968820012020-09-16
07325710004906Cabinet68820742020-09-16
07325710011331Humidifier holder for rail 10 x 25/10 x 30 mm65451102020-09-16
17325710004248Dust filter 20 pcs/pkg68834412020-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501287BREATHING MASK Single Use Size 0ASSOMEDIKA, OOOBSJ2026-05-26
04816415501294BREATHING MASK Single Use Size 3ASSOMEDIKA, OOOBSJ2026-05-26
04816415501300BREATHING MASK Single Use Size 6ASSOMEDIKA, OOOBSJ2026-05-26
04816415501317BREATHING MASK Reusable Size 0ASSOMEDIKA, OOOBSJ2026-05-26
04816415501324BREATHING MASK Reusable Size 3ASSOMEDIKA, OOOBSJ2026-05-26
04816415501331BREATHING MASK Reusable Size 5ASSOMEDIKA, OOOBSJ2026-05-26
50192253071410CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071427CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071434CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071441CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071458CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071465CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
44710810080836N/AGALEMED CORPORATIONBSJ2026-03-05
44710810081789N/AGALEMED CORPORATIONBSJ2026-03-05
44710810081819N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082250N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082267N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082403N/AGALEMED CORPORATIONBSJ2026-03-05
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44710810088702N/AGALEMED CORPORATIONBSJ2026-03-05
44710810115781N/AGALEMED CORPORATIONBSJ2026-03-05
44710810117631N/AGALEMED CORPORATIONBSJ2026-03-05
44710810117624N/AGALEMED CORPORATIONBSJ2026-03-04
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05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22FIntersurgical IncorporatedBSJ2025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22FIntersurgical IncorporatedBSJ2025-09-25