DEVICE: RUSCH (04026704053889)
Device Identifier (DI) Information
RUSCH
IPN052293
In Commercial Distribution
403900-000100
TELEFLEX INCORPORATED
IPN052293
In Commercial Distribution
403900-000100
TELEFLEX INCORPORATED
Bladder catheter, whistle tip, 1 eye
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
42433 | Intermittent urethral drainage catheter, non-antimicrobial, reusable |
A flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KOD | CATHETER, UROLOGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 10 French |
Device Record Status
f7607b87-458c-429d-9850-5d7e85b31d64
June 19, 2020
4
September 16, 2016
June 19, 2020
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
44026704053887 | 42 | 24026704053883 | In Commercial Distribution | Carton | |
24026704053883 | 10 | 04026704053889 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(919)544-8000
CS@TELEFLEX.COM
CS@TELEFLEX.COM