AccessGUDID - DEVICE: ZOOM™ Reperfusion Catheter (00812212030184)

GUDID

Device Identifier (DI) Information

Brand Name: ZOOM™ Reperfusion Catheter
Version or Model: ICRC035158
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ICRC035158
Company Name: IMPERATIVE CARE, INC.

Primary DI Number: 00812212030184
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080816678 *Terms of Use

Device Description: ZOOM 035 158 cm RC

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?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRY	Catheter, Thrombus Retriever

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183043	000
K202182	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: 158 Centimeter
Outer Diameter: 0.051 Inch
Lumen/Inner Diameter: 0.035 Inch

Device Record Status

Public Device Record Key: 4ca6d8c4-2d6a-473d-a638-dfbb68679b5e
Public Version Date: November 09, 2022
Public Version Number: 6
DI Record Publish Date: August 10, 2020