DEVICE: andorate® Air/Water Bottle Tubing (04897106950065)

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Device Record History
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Device Identifier (DI) Information
andorate® Air/Water Bottle Tubing
GAR072US
Not in Commercial Distribution

GA Health Company Limited
04897106950065
GS1
February 16, 2022
1
686908512 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
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?
60738 Endoscopic insufflation tubing set, single-use
A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OCX Endoscopic Irrigation/Suction System
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
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
5288281f-d289-4d61-b8b8-ed49305c25d9
August 08, 2024
5
May 28, 2020
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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
14897106950062 10 04897106950065 2022-02-16 Not in Commercial Distribution Box
24897106950069 4 14897106950062 2022-02-16 Not in Commercial Distribution Carton
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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