FDA.report

Gas Sampling Line With Reflective Luer

Primary DI
10709078007191
Brand
Gas Sampling Line With Reflective Luer
Company
WESTMED, INC.
Model
0944
Device description
Gas Sampling Line With Reflective Luer 10' PVC, .038" ID x .107" OD, Swivel Elbow, Reflective Luer, Gas Sampling Tee for Use In High Humidity Environments
Published
2019-06-30
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
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078007191PackageGS125In Commercial Distribution
00709078007194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800719110709078007191
00709078007194007090780071947090780071940709078007194

GMDN Terms

TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible tube(s) primarily intended to be used as an interface between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
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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