AccessGUDID - DEVICE: Malibu Aspiration Catheter System (00850041053059)

GUDID

Device Identifier (DI) Information

Brand Name: Malibu Aspiration Catheter System
Version or Model: MALIBU16-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Innova Vascular, Inc.

Primary DI Number: 00850041053059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118406653 *Terms of Use

Device Description: One (1) Malibu Aspiration Catheter System: Malibu Aspiration Catheter, Dilator, and Syringe

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:	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?
66971	Thrombectomy suction catheterization kit	A collection of devices intended to be used during a percutaneous transluminal thrombectomy suction procedure (in conjunction with a syringe or dedicated suction pump system) and which includes a thrombectomy suction catheter and additional devices intended to support catheter introduction and function (e.g., dilator, clot buster, haemostasis valve, aspiration tubing). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEW	Peripheral Mechanical Thrombectomy With Aspiration
KRA	Catheter, Continuous Flush

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: 56b5a680-b68a-4958-893d-d2e7e9e05a3d
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024