AccessGUDID - DEVICE: Zenysis Dual Lumen Acute Dialysis Catheter (00801741109768)

GUDID

Device Identifier (DI) Information

Brand Name: Zenysis Dual Lumen Acute Dialysis Catheter
Version or Model: A853240
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A853240
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741109768
Issuing Agency: GS1
Commercial Distribution End Date: August 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: Zenysis DL, 24cm ST Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60879	Haemodialysis catheterization kit	A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access 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 includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). 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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Centimeter
Catheter Gauge: 11 French

Device Record Status

Public Device Record Key: d4d879c1-36e8-4fe2-a65e-a0ea9f7f19ec
Public Version Date: September 26, 2024
Public Version Number: 3
DI Record Publish Date: February 11, 2016