ZOOM™ Reperfusion Catheter

Basic Information

• Brand Name: ZOOM™ Reperfusion Catheter
• Primary DI: 00812212030207
• Version / Model: ICRC035158
• Catalog Number: ICRC035158
• Company Name: IMPERATIVE CARE, INC.
• Labeler DUNS: 080816678
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-15
• Public Version: 3
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: e91f794f-e3e6-429e-a7cc-fa68c8983746

Device Description

ZOOM 035 160 cm RC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRY	Catheter, Thrombus Retriever	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812212030207	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K202182	000

Device Sizes

Type	Value	Unit	Text
Catheter Length	160	Centimeter
Outer Diameter	0.051	Inch
Lumen/Inner Diameter	0.035	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place at room temperature.