AccessGUDID - DEVICE: MAHURKAR Elite (10884521788459)

GUDID

Device Identifier (DI) Information

Brand Name: MAHURKAR Elite
Version or Model: 8888211424
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mozarc Medical US LLC

Primary DI Number: 10884521788459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118997146 *Terms of Use

Device Description: Acute Dual Lumen Catheter Tray High Flow 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":	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 [?]
K120674	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
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Centimeter
Catheter Gauge: 13.5 French

Device Record Status

Public Device Record Key: 5b335dbf-b661-4d97-9072-076e6a1938a1
Public Version Date: April 29, 2025
Public Version Number: 8
DI Record Publish Date: May 06, 2021