DEVICE: ARROW (20801902006015)

Device Identifier (DI) Information

ARROW
IPN033960
In Commercial Distribution
AK-22122
TELEFLEX INCORPORATED
20801902006015
GS1

1
002348191 *Terms of Use
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter for High Volume Infusions
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
Yes
Yes
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?
46979 Double-lumen haemodialysis catheter, nonimplantable
A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein 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 and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MPB CATHETER, HEMODIALYSIS, NON-IMPLANTED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K993933 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Avoid Freezing, 0 deg. C and excessive heat above 40 deg. C
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 12 French
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Device Record Status

a16edbfc-fb85-4ac0-aaae-c4bac86c4176
February 05, 2021
4
August 02, 2017
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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
10801902006018 5 20801902006015 2017-11-09 Not in Commercial Distribution Case
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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
No
No CLOSE

Customer Contact

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