DEVICE: 6130A (00850015328022)

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Device Record History
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Device Identifier (DI) Information
6130A
6130A
In Commercial Distribution

ARC MEDICAL INC.
00850015328022
GS1

1
624880720 *Terms of Use
No description.
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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?
46816 Heat/moisture exchanger/microbial medical gas filter
A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAH Filter, Bacterial, Breathing-Circuit
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K090738 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
8ba3d53c-3da3-4de6-947c-a45c309941f4
December 22, 2021
2
January 15, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50850015328027 600 00850015328022 In Commercial Distribution
40850015328020 300 00850015328022 In Commercial Distribution
30850015328023 100 00850015328022 In Commercial Distribution
20850015328026 50 00850015328022 In Commercial Distribution
10850015328029 10 00850015328022 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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