DEVICE: Adapter Set for Olympus EUS Linear (00843356101195)

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Device Record History
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Device Identifier (DI) Information
Adapter Set for Olympus EUS Linear
ASO5E
In Commercial Distribution

CYGNUS MEDICAL L.L.C.
00843356101195
GS1

1
103169095 *Terms of Use
Adapter Set for Olympus EUS Linear (1) AIR WATER/SUCTION FLOW (1) SUCTION PLUG (1) LL-MALE CAP - Non-Vented Male Luer Lock Cap, Recessed Stem, Light Blue (1) TS-M4.7-20MM-WH-STANDOFF ETTINGER PART NUMBER: 05.34.200 FEMALE TO FEMALE 20MM STANDOFF, M4 THREAD, NATURAL/WHITE COLOR, GLASS FIBER REINFORCED NYLON -1 Set / 100 Sets per Case
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
65046 Endoscope dryer
An electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JRJ Unit, Drying
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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

[?]
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
6c8f6d51-1065-41e1-878c-bc0a09c00820
March 17, 2023
2
March 03, 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
10843356101192 100 00843356101195 In Commercial Distribution
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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