FDA.reportPublic FDA data

Zoom 6F Insert Catheter, SIM

Primary DI
00812212030696
Brand
Zoom 6F Insert Catheter, SIM
Company
IMPERATIVE CARE, INC.
Model
IC6FSIM143
Catalog number
IC6FSIM143
Device description
Zoom 6F Insert Catheter, SIM, 143cm
Published
2024-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233975000Zoom 6F Insert CathetersImperative Care, Inc.2024-04-02DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812212030696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812212030696008122120306968122120306960812212030696

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length143Centimeter
Lumen/Inner Diameter0.041Inch
Outer Diameter0.082Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, Specify00Store in a cool, dry place at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-408-502-7548CustomerService@Imperativecare.com

Regulatory Flags#

DUNS number
080816678
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812212030764Zoom 4S CatheterICRC04S160ICRC04S1602025-11-24
00812212030771Zoom 4S CatheterICRC04S144ICRC04S1442025-11-24
00812212030788Zoom 4S CatheterICRC04S125ICRC04S1252025-11-24
00812212030795Ikon 14 GuidewireICGW014200SICGW014200S2025-11-24
00812212030801Ikon 14 GuidewireICGW014300SICGW014300S2025-11-24
00812212030818Ikon 14 Pro GuidewireICGW014200PICGW014200P2025-11-24
00812212030825Ikon 14 Pro GuidewireICGW014300PICGW014300P2025-11-24
00812212030832Ikon 18 GuidewireICGW018200SICGW018200S2025-11-24
00812212030856Ikon 18 Pro GuidewireICGW018200PICGW018200P2025-11-24
00812212030863Ikon 18 Pro GuidewireICGW018260PICGW018260P2025-11-24
00812212030887Ikon 24 GuidewireICGW024200SICGW024200S2025-11-24
00812212030900Ikon 24 Pro GuidewireICGW024200PICGW024200P2025-11-24
00812212030474Zoom CatheterICRC055137ICRC0551372022-07-08
00812212030498Zoom CatheterICRC045144ICRC0451442022-07-08
00812212030443Zoom CatheterICRC035158ICRC0351582021-11-17
00812212030450Zoom CatheterICRC071137ICRC0711372021-10-18
00812212030337TracStar LDP Large Distal PlatformICAC088095ICAC0880952021-09-22
00812212030344TracStar LDP Large Distal PlatformICAC088105ICAC0881052021-09-22
00850032079167Symphony™ Clot ContainerSYMPHONYCCSYMPHONYCC2024-02-02
00850032079211Symphony™ 16F 82cm CatheterSYMPHONY16F 82SYMPHONY16F822024-08-09

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