DEVICE: GENTLECATH (04026704582532)

Device Identifier (DI) Information

GENTLECATH
421437
In Commercial Distribution
421437
CONVATEC, PURCHASING DEPARTMENT
04026704582532
GS1

1
809784593 *Terms of Use
CVT GENTLECATH CLOSED RDRUB CH16
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Indwelling urethral drainage catheter A sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Commonly known as a Foley catheter, it is intended to be introduced by a healthcare professional. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
KOD Catheter, Urological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010420 000
No CLOSE

Sterilization

Yes
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
Device Size Text, specify: 16 FR
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Device Record Status

3fa4597f-aa7a-4eb3-a23e-61c49e3b4780
September 24, 2018
6
September 09, 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
24026704582536 100 04026704582532 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

[?]
1-800-422-8811
cic@convatec.com
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