DEVICE: RUSCH (04026704550586)

Device Identifier (DI) Information

RUSCH
IPN053618
In Commercial Distribution
ECS140
TELEFLEX INCORPORATED
04026704550586
GS1

1
002348191 *Terms of Use
14FR Soft
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KOD CATHETER, UROLOGICAL
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000070 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify:
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Width: 2.6 Inch
Height: 0.28 Inch
Length: 10.6 Inch
CLOSE

Device Record Status

75f42e5d-571b-41c3-bbff-d70148d861b7
September 24, 2018
6
September 16, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
44026704550584 10 24026704550580 In Commercial Distribution Case
24026704550580 50 04026704550586 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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