DEVICE: Dover (10884521016613)

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Device Record History
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Device Identifier (DI) Information
Dover
2822
In Commercial Distribution
2822
Cardinal Health, Inc.
10884521016613
GS1
December 31, 2025
1
080935429 *Terms of Use
Hydrogel Coated Latex Foley Catheter,30 mL, 3-Way
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Device Characteristics
Labeling does not contain MRI Safety Information
Yes
No
Yes
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?
34930 Single-administration urethral drainage/irrigation catheter
A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KOD CATHETER, UROLOGICAL
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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
Special Storage Condition, Specify: This Side Up;
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 30 Milliliter
Catheter Gauge: 22 French
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Device Record Status
5e4b7d66-358c-4546-8623-77d53d47901d
August 11, 2023
8
September 24, 2016
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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
30884521016617 12 10884521016613 2025-12-31 In Commercial Distribution PACK_OR_INNER_PACK
20884521016610 120 10884521016613 2025-12-31 In Commercial Distribution CASE
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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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