FDA.report

DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#1 IN

Primary DI
04716770652146
Brand
DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#1 IN
Company
BESMED HEALTH BUSINESS CORP.
Model
CM-65214
Device description
DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#1 INFANT LARGE
Published
2017-10-20
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

Related Records

Product Codes

CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04716770652146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04716770652146047167706521464716770652146

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
658023775
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

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