DEVICE: Dover (10884521003460)

Device Identifier (DI) Information

Dover
8884733900
Not in Commercial Distribution
8884733900
Cardinal Health, Inc.
10884521003460
GS1
August 31, 2024
1
080935429 *Terms of Use
Urine Leg Bag with Extension Tube
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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?
58921 Non-wearable adult urine collection bag, open-ended
A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. 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: ;
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Clinically Relevant Size

[?]
Size Type Text
Length: 18 Inch
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Device Record Status

e30a6d9b-1c52-4018-a066-70e6736681e4
September 02, 2024
9
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
20884521003467 24 10884521003460 2024-08-31 Not in Commercial Distribution CASE
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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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