FDA.report

SWIVEL OXYGEN MASK, CHILD WITH 7FT TUBE,SINGLE PAC

Primary DI
04716770815220
Brand
SWIVEL OXYGEN MASK, CHILD WITH 7FT TUBE,SINGLE PAC
Company
BESMED HEALTH BUSINESS CORP.
Model
OM-81522
Device description
SWIVEL OXYGEN MASK, CHILD WITH 7FT TUBE,SINGLE PACKING
Published
2017-12-20
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
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04716770815220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04716770815220047167708152204716770815220

GMDN Terms

TermDefinition
Respiratory oxygen therapy systemAn assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.

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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