AccessGUDID - DEVICE: ARROW (00801902007292)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN035358
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU-25122-F
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 00801902007292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: You-Bend(TM) Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter for High Volume Infusions

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
MPB	CATHETER, HEMODIALYSIS, NON-IMPLANTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993933	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 9261f40d-b4fd-4a49-bbe7-7bbb478c0b24
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: October 16, 2015