FDA.reportPublic FDA data

Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILGE)

Primary DI
05055788777403
Brand
Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILGE)
Company
FLEXICARE MEDICAL LIMITED
Model
2106570-031
Device description
Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILGE)
Published
2020-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05055788777403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788777403050557887774035055788777403

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.

Regulatory Flags#

DUNS number
504406273
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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