FDA.report

Adult CO2 /O2 Mask

Primary DI
10709078006873
Brand
Adult CO2 /O2 Mask
Company
WESTMED, INC.
Model
0931
Device description
Pediatric Elongated CO2/O2 Mask 7' Tubing w/ Threaded Nut, Swivel GSE, 10' x 0.38" ID x .107" OD, Reflective Luer Connectors
Published
2019-05-06
Public version status
New
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
10709078006873PackageGS125In Commercial Distribution
00709078006876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800687310709078006873
00709078006876007090780068767090780068760709078006876

GMDN Terms

TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
false
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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