AccessGUDID - DEVICE: 15.5F X 28CM JET FLOW PRE-CURVED LT CATHETER (00810988020064)

GUDID

Device Identifier (DI) Information

Brand Name: 15.5F X 28CM JET FLOW PRE-CURVED LT CATHETER
Version or Model: JT021552801
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JT021552801
Company Name: JET MEDICAL, INC.

Primary DI Number: 00810988020064
Issuing Agency: GS1
Commercial Distribution End Date: March 04, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 079506014 *Terms of Use

Device Description: No description.

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:	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?
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 [?]
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: 28 Centimeter
Catheter Gauge: 15.5 French

Device Record Status

Public Device Record Key: a09998c3-6c5e-48c4-be2b-0292a5deedf3
Public Version Date: March 05, 2025
Public Version Number: 4
DI Record Publish Date: July 20, 2015