DEVICE: Conveen Active (05708932135047)

Device Identifier (DI) Information

Conveen Active
25502
In Commercial Distribution
25502
Coloplast A/S
05708932135047
GS1

1
305524696 *Terms of Use
Urine collection bag, leg bag with integrated strap, inlet tube: 2.8 inch (7cm)
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Device Characteristics

MR Safe
No
Yes
Yes
No
Yes
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?
58923 Wearable adult urine collection bag, open-ended
A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NNW BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
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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
Total Volume: 250 Milliliter
Length: 7 Centimeter
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Device Record Status

e8f2a68e-d4a6-4d20-8784-9ca05a70d9e5
March 21, 2022
1
March 11, 2022
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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
05708932505567 30 05708932135047 In Commercial Distribution Retail Box
05708932505574 4 05708932505567 In Commercial Distribution Shipper Box
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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