DEVICE: INTER THERM T HME (05030267161799)

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Device Record History
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Device Identifier (DI) Information
INTER THERM T HME
1875020
In Commercial Distribution

Intersurgical Incorporated
05030267161799
GS1

1
785952607 *Terms of Use
INTER THERM T HME
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Device Characteristics
Labeling does not contain MRI Safety Information
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Yes
Yes
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No
Yes
No

GMDN

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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?
35530 Heat/moisture exchanger, single-use
A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
BYD Condenser, Heat And Moisture (Artificial Nose)
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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

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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
07c16051-d8c7-4b02-b4d0-2fa3ed88faf6
February 11, 2025
2
May 18, 2022
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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
05030267161812 100 05030267161799 In Commercial Distribution
05030267161805 25 05030267161799 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
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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