Zoom 7X Catheter ICRC07X137

GUDID 00812212030757

Zoom 7X Catheter, 137cm

IMPERATIVE CARE, INC.

Thrombectomy suction catheter
Primary Device ID00812212030757
NIH Device Record Keyb79cfcf5-3e44-4e61-ba0e-7e96af9ac998
Commercial Distribution StatusIn Commercial Distribution
Brand NameZoom 7X Catheter
Version Model NumberICRC07X137
Catalog NumberICRC07X137
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
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com

Device Dimensions

Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 Centimeter
Lumen/Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Catheter Length137 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100812212030757 [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 Date2025-06-17
Device Publish Date2025-06-09

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00812212030818 - Ikon 14 Pro Guidewire2025-12-02 Imperative Care Neurovascular Guidewire-Support, 0.014", 200cm
00812212030825 - Ikon 14 Pro Guidewire2025-12-02 Imperative Care Neurovascular Guidewire-Support, 0.014", 300cm
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