24 Fr Evacuation System

Primary DI
00810123710485
Brand
24 Fr Evacuation System
Company
Inari Medical, Inc.
Model
131-102 / AS-01229
Device description
24 Fr Evacuation System
Published
2024-10-10
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
PURVacuum Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PURVacuum SyringeGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233069000Removal System Large Bore 60 cc SyringeInari Medical, Inc.2024-03-26PUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123710485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123710485008101237104858101237104850810123710485

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18779234747info@inarimedical.com

Regulatory Flags#

DUNS number
076827459
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123710249Artix AX31-1012026-01-06
00810123710256Artix AX31-1022026-01-06
00810123710270Intri26 Introducer Sheath52-1022026-01-06
00810123710126InThrill Thrombectomy Catheter43-10243-1022025-05-30
00810123710294InThrill Sheath53-10153-1012025-05-30
00810123710157FlowTriever2 Catheter11-10211-1022025-05-28
00810123710393ClotTriever BOLD Catheter42-1022025-04-09
00850291007352InThrill Thrombectomy Catheter43-10243-1022024-12-20
00850291007697Large Bore 60 cc Syringe99-10299-1022024-12-20
00810123710577Artix Thin-Walled Sheath30-104 / AS-012062024-11-11
00810123710584Artix MT32-102 / AS-012482024-11-11
00810123710591Artix MT32-103 / AS-0124432-1032024-11-11
00810123710560Artix Thin-Walled Sheath30-103 / AS-012162024-11-07
0081012371047816 Fr Evacuation System131-101 / AS-012262024-10-10
00850041730165LimFlow Crossing Stent GraftRGS-35060-US-242024-10-08
00850041730172LimFlow Crossing Stent GraftRGS-40060-US-242024-10-08
00850041730189LimFlow Extension Stent GraftRGS-55060-US-242024-10-08
00850041730196LimFlow Extension Stent GraftRGS-55100-US-242024-10-08
00850041730202LimFlow Extension Stent GraftRGS-55150-US-242024-10-08
00850041730219LimFlow Extension Stent GraftRGS-55200-US-242024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081012371047816 Fr Evacuation SystemInari Medical, Inc.PUR2024-10-10
00884450682951Merit Medical®Merit Medical Systems, Inc.PUR2024-05-15
00884450610725VacLok AT™Merit Medical Systems, Inc.PUR2022-10-20
10884450610722VacLok AT™Merit Medical Systems, Inc.PUR2022-10-20
00884450610718VacLok AT™Merit Medical Systems, Inc.PUR2022-08-06
20884450610712VacLok AT™Merit Medical Systems, Inc.PUR2022-08-06
00884450271780VacLok AT™Merit Medical Systems, Inc.PUR2017-10-16
00884450271797VacLok AT™Merit Medical Systems, Inc.PUR2017-10-16
10884450271787VacLok AT™Merit Medical Systems, Inc.PUR2017-10-16
20884450271791VacLok AT™Merit Medical Systems, Inc.PUR2017-10-16