DEVICE: ARROW (00801902039279)
Device Identifier (DI) Information
ARROW
IPN035666
In Commercial Distribution
CS-15242-SPM
TELEFLEX INCORPORATED
IPN035666
In Commercial Distribution
CS-15242-SPM
TELEFLEX INCORPORATED
15 Fr. 19 CM Cannon(R) II Plus / Arrow Simplicity(TM) Hemodialysis Catheterization Kit Long-Term Access. Catheter length, Cuff to Tip: 19 cm
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
37278 | Double-lumen haemodialysis catheter, implantable |
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MSD | Catheter, hemodialysis, implanted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K111117 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 15 French |
Length: 19 Centimeter |
Device Record Status
33eca249-5dc4-4f52-8dbe-f2035f3d442b
February 05, 2021
6
October 16, 2015
February 05, 2021
6
October 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30801902039270 | 1 | 50801902039274 | 2019-10-07 | Not in Commercial Distribution | Case |
50801902039274 | 1 | 00801902039279 | 2019-10-07 | Not 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