DEVICE: PENTAX Medical (04961333237562)

Device Identifier (DI) Information

PENTAX Medical
OE-C29
In Commercial Distribution

HOYA CORPORATION
04961333237562
GS1

1
691519705 *Terms of Use
PENTAX Medical Ventilating Connector Adapter OE-C29
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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
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDF Colonoscope And Accessories, Flexible/Rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K190805 000
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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

d21ae770-c6b1-48c6-9e96-febcb274cf3c
August 08, 2023
1
July 31, 2023
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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

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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)

[?]
Yes
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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