DEVICE: Dover (10884521154278)

Device Identifier (DI) Information

Dover
6946
Not in Commercial Distribution
6946
Cardinal Health, Inc.
10884521154278
GS1
June 30, 2024
1
080935429 *Terms of Use
Hydrogel Coated Latex Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Needle Sampling
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
Yes
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?
32031 Indwelling urethral catheterization kit, adult
A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNX COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry;AVOID DIRECT SUNLIGHT
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 16 French
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Device Record Status

bc417d60-b50c-462a-b817-e99d1200249a
July 01, 2024
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
20884521154275 10 10884521154278 2024-06-30 Not 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

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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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