DEVICE: Perma Pure (00840106904518)

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Device Record History
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Device Identifier (DI) Information
Perma Pure
ME Series
In Commercial Distribution
ME-050-03-270
PERMA PURE LLC
00840106904518
GS1

1
063142533 *Terms of Use
ME-050-30MS/ML
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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

[?]
Size Type Text
No Device Sizes
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Device Record Status
fd233dac-d148-4b00-b663-1223caa31725
August 05, 2022
2
October 09, 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
00840106904556 50 00840106904518 In Commercial Distribution Inner Pack
00840106904549 25 00840106904518 In Commercial Distribution Inner Pack
00840106904532 10 00840106904518 In Commercial Distribution Inner Pack
00840106904525 5 00840106904518 In Commercial Distribution Inner Pack
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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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