FDA.reportPublic FDA data

ZOOM™ 88 Large Distal Platform

Primary DI
00812212030146
Brand
ZOOM™ 88 Large Distal Platform
Company
IMPERATIVE CARE, INC.
Model
ICFC088100
Catalog number
ICFC088100
Device description
ZOOM™ 88 6F 088 LDP, 100 cm
Published
2019-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180169000EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm LengthImperative Care, Inc.2018-08-08DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812212030023PreviousGS10
00812212030146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812212030023008122120300238122120300230812212030023
00812212030146008122120301468122120301460812212030146

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Lumen/Inner Diameter0
Outer Diameter0

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.

Contacts#

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

Regulatory Flags#

DUNS number
080816678
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00812212030108TracStar™ Large Distal PlatformICAC088080ICAC0880802019-04-30
00812212030115TracStar™ Large Distal PlatformICAC088090ICAC0880902019-04-30
00812212030153ZOOM™ 88 Large Distal PlatformICFC088110ICFC0881102019-04-30
00812212030573Zoom 88 Large Distal Platform SupportICTC088100SICTC088100S2023-06-02
00812212030511Zoom RDL Radial Access System, 95cmICTC088095RICTC088095R2022-09-28
00812212030528Zoom RDL Radial Access System, 105cmICTC088105RICTC088105R2022-09-28
00812212030535Zoom RDL Radial Access System, 110cmICTC088110RICTC088110R2022-09-28
00812212030566Zoom RDL Radial Access System, 103cmICTC088103RICTC088103R2022-09-28
00812212030399TracStar™ Large Distal PlatformICAC088095ICAC0880952022-08-11
00812212030405ZOOM™ 88 Large Distal PlatformICTC088110ICTC0881102022-08-11
00812212030467TracStar™ Large Distal PlatformICAC088105ICAC0881052022-08-11
00812212030337TracStar LDP Large Distal PlatformICAC088095ICAC0880952021-09-22
00812212030344TracStar LDP Large Distal PlatformICAC088105ICAC0881052021-09-22
00812212030351ZOOM™ 88 Large Distal PlatformICTC088100ICTC0881002021-09-22
00812212030368Zoom 88 Large Distal PlatformICTC088110ICTC0881102021-09-22
00812212030504ZOOM™ 88-T Large Distal PlatformICTC088110ICTC0881102021-09-22
00812212030160ZOOM™ 88-T Large Distal PlatformICTC088100ICTC0881002020-03-06

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Primary DI, Brand, Company table
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