AccessGUDID - DEVICE: MAHURKAR (20884521128061)

GUDID

Device Identifier (DI) Information

Brand Name: MAHURKAR
Version or Model: 8888104004HP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mozarc Medical US LLC

Primary DI Number: 20884521128061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118997146 *Terms of Use

Device Description: Acute High Pressure Triple Lumen Catheter Tray,Straight Extensions with IC* Safety Components

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	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?
61629	Triple-lumen haemodialysis catheter	A sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enable central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes three lumens, two dedicated to coaxial flow of blood for dialysis, and the third intended for independent IV access. Devices dedicated to catheter introduction/function may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NIE	CATHETER, HEMODIALYSIS, TRIPLE LUMEN, 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
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Centimeter
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: c85b6ae1-176b-4962-bb6e-0d06cb8d157e
Public Version Date: April 29, 2025
Public Version Number: 11
DI Record Publish Date: August 31, 2015