DEVICE: Medline (10080196170982)

Device Identifier (DI) Information

Medline
DYND11532
In Commercial Distribution
DYND11532
MEDLINE INDUSTRIES, INC.
10080196170982
GS1

1
025460908 *Terms of Use
CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
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
EZL CATHETER, RETENTION TYPE, BALLOON
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082815 000
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: Store product away from direct exposure to light at room temperature
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0c9f7084-be35-4f35-852e-9b1e2bf61434
December 04, 2020
4
October 14, 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
40080196170983 10 10080196170982 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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)633-5463
service@medline.com
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