AccessGUDID - DEVICE: ARROW (10801902126730)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN001304
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACS-15272-VF
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10801902126730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Arrow-Clark(TM) VectorFlow(TM) Retrograde Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to Cuff: 27 cm

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
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?
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 [?]
K141051	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 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Store between 20 - 25C (68 - 77F).

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04c10fe8-3f0b-4584-86bc-47f209ee5907
Public Version Date: January 16, 2025
Public Version Number: 8
DI Record Publish Date: September 16, 2016