DEVICE: PENTAX (04961333085132)

Device Identifier (DI) Information

PENTAX
OF-B153
In Commercial Distribution

HOYA CORPORATION
04961333085132
GS1

1
691519705 *Terms of Use
AIR/WATER/SUCTION CHANNEL CLEANING ADAPTER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
64509 Endoscope leak tester tubing
A length of flexible tube with connectors intended to deliver a medium (typically air) from a leak tester to the interior of an endoscope during a leak test; it may in addition be intended for other endoscope pre- or post-procedural processing (e.g., allow connection of a fluid seal). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FDS Gastroscope and accessories, flexible/rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131902 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide
Moist Heat or Steam Sterilization
Sound Waves
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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

4033414b-08f2-4ffb-b351-3b382829fa07
April 07, 2025
8
April 07, 2017
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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
No Package DIs found
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Secondary DI

[?]
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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