FDA.report

CARDINAL HEALTH

Primary DI
50192253071441
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
INFMASK1
Catalog number
INFMASK1
Device description
MASK FLEXIBLE INFANT SIZE 1
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BSJMASK, GAS, ANESTHETIC

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253071441PackageGS150In Commercial Distribution
10192253071443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225307144150192253071441
1019225307144310192253071443

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length79Millimeter
Width67Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
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10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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Primary DIBrandCompanyProduct codePublished
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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
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