Zoom 4S Catheter ICRC04S125

GUDID 00812212030788

Zoom 4S Reperfusion Catheter, 125cm

IMPERATIVE CARE, INC.

Thrombectomy suction catheter
Primary Device ID00812212030788
NIH Device Record Keyf47dbd02-10b2-4986-ba82-342663d52694
Commercial Distribution StatusIn Commercial Distribution
Brand NameZoom 4S Catheter
Version Model NumberICRC04S125
Catalog NumberICRC04S125
Company DUNS080816678
Company NameIMPERATIVE CARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com

Device Dimensions

Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter
Lumen/Inner Diameter0.045 Inch
Outer Diameter0.062 Inch
Catheter Length125 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100812212030788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

On-Brand Devices [Zoom 4S Catheter]

00812212030788Zoom 4S Reperfusion Catheter, 125cm
00812212030771Zoom 4S Reperfusion Catheter, 144cm
00812212030764Zoom 4S Reperfusion Catheter, 160cm
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