DEVICE: N/A (04961333243402)

Device Identifier (DI) Information

N/A
KUMOF-B53K
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333243402
GS1

10
083211284 *Terms of Use
VALVE, SUCTION 10 PCS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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?
61793 Endoscope suction valve, reusable
A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EOQ Bronchoscope (Flexible Or Rigid)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K951199 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant
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

84787c99-f6d8-465b-8817-a756d0ec7e6a
July 25, 2024
3
March 14, 2018
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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: 14961333243409 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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