DEVICE: PERMA PURE (00810020360080)

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Device Record History
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Device Identifier (DI) Information
PERMA PURE
ME Series
In Commercial Distribution
ME-050-03-266
PERMA PURE LLC
00810020360080
GS1

1
063142533 *Terms of Use
ME-050-03-266 Nafion Dryer 1 Each
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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
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
e6cb2981-b706-47c8-9968-6bf3f85a2779
October 23, 2024
1
October 15, 2024
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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
00810020360097 5 00810020360080 In Commercial Distribution Inner
00810020360103 25 00810020360080 In Commercial Distribution Inner
00810020360110 50 00810020360080 In Commercial Distribution Inner
00810020360127 100 00810020360080 In Commercial Distribution Inner
00810020360134 250 00810020360080 In Commercial Distribution Inner
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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