AccessGUDID - DEVICE: Zoom 6F Insert Catheter, VTK (00812212030603)

GUDID

Device Identifier (DI) Information

Brand Name: Zoom 6F Insert Catheter, VTK
Version or Model: IC6FVTK140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IC6FVTK140
Company Name: IMPERATIVE CARE, INC.

Primary DI Number: 00812212030603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080816678 *Terms of Use

Device Description: Zoom 6F Insert Catheter, VTK, 140cm

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:	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?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, Intravascular, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233975	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
Special Storage Condition, Specify: Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, Specify: Store in a cool, dry place at room temperature.

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 140 Centimeter
Outer Diameter: 0.082 Inch
Lumen/Inner Diameter: 0.041 Inch

Device Record Status

Public Device Record Key: 41c78406-24e5-449e-a1a8-2f7af6c722fc
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: June 18, 2024