DEVICE: Gas Sampling Line With Reflective Luer (00709078007194)

Device Identifier (DI) Information

Gas Sampling Line With Reflective Luer
0944
Not in Commercial Distribution

WESTMED, INC.
00709078007194
GS1
March 31, 2023
1
092673953 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45566 Gas-sampling/monitoring respiratory tubing, single-use
A length of flexible noninvasive tube(s) primarily intended to be connected 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] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BZO Set, Tubing And Support, Ventilator (W Harness)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

151d7e49-4f02-49b3-ad96-74be8eb54323
March 31, 2023
5
June 30, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10709078007191 25 00709078007194 2023-03-31 Not in Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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