AccessGUDID - DEVICE: Catheter w/ Blunt Introducer (10816203022056)

GUDID

Device Identifier (DI) Information

Brand Name: Catheter w/ Blunt Introducer
Version or Model: VV13F
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ORIGEN BIOMEDICAL, INC.

Primary DI Number: 10816203022056
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 625272232 *Terms of Use

Device Description: ECMO Reinforced Dual Lumen Cannula, 13F

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:	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?
58726	Mobile extracorporeal gas exchange system catheter kit	A collection of sterile devices that is a component of a mobile extracorporeal gas exchange system and which includes a dedicated dual-lumen venous catheter. The catheter is designed to conduct blood from the patient and return it to the venous system (veno-venous) after extracorporeal circulation and gas exchange; it is intended for use with femoral or jugular veins and is designed for low-resistance to flow while also resisting kinks. In addition to the catheter, the kit typically includes a syringe, needles, guidewires, a scalpel, and dilators. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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
No Device Sizes

Device Record Status

Public Device Record Key: b90b2bc1-d6f7-4b96-8a77-a1f9c5eba4b1
Public Version Date: December 13, 2024
Public Version Number: 3
DI Record Publish Date: September 23, 2016