DEVICE: RUSCH (04026704550777)

Device Identifier (DI) Information

RUSCH
IPN053658
In Commercial Distribution
ONC-14
TELEFLEX INCORPORATED
04026704550777
GS1

1
002348191 *Terms of Use
14FR
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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?
34917 Indwelling urethral drainage balloon catheter, non-antimicrobial
A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed 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). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KOD CATHETER, UROLOGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010420 000
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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: 11 Inch
Height: 0.5 Inch
Width: 6.5 Inch
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Device Record Status

eea1a255-294c-4d66-a82a-e693e8c1cbef
December 04, 2020
9
September 16, 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
24026704550771 100 04026704550777 In Commercial Distribution 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
Yes
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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