AccessGUDID - DEVICE: MAHURKAR (10884521005464)

GUDID

Device Identifier (DI) Information

Brand Name: MAHURKAR
Version or Model: 8888115243
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Mozarc Medical US LLC

Primary DI Number: 10884521005464
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 118997146 *Terms of Use

Device Description: Acute Dual Lumen Catheter Tray,Pre-Curved with IC* Components,11.5 Fr/Ch (3.8 mm) x 24 cm

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:	No
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
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days

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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: French Catheter, 11.5, Guage;
Catheter Gauge: 11.5 French
Length: 24 Centimeter

Device Record Status

Public Device Record Key: f8001183-1d91-49cc-8a8d-2205023af727
Public Version Date: April 29, 2025
Public Version Number: 12
DI Record Publish Date: October 22, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521005461	5	10884521005464	2020-07-31	Not in Commercial Distribution	PACK_OR_INNER_PACK
10884521519459	20	20884521005461	2020-07-31	Not in Commercial Distribution	CASE