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
00810123710157FlowTriever2 Catheter11-10211-1022025-05-28
00810123710430ClotTriever Sheath, 16 Fr51-101/ AS-0126251-1012023-12-15
00810123710522Triever20 Curve21-201/ AS-0115921-2012023-12-15
00850291007277ClotTriever XL CatheterAS-023541-1022023-05-09
00850291007321Artix BG30-10130-1012023-05-09
00850291007376Artix™ AX31-10131-1012023-04-24
00850291007260Intri24 Introducer Sheath52-10152-1012023-03-20
00850291007239FlowStasis70-1012021-03-22
00850291007017FlowTriever Catheter, M10-1022016-09-15
00850291007048FlowTriever30-1012016-09-15
00850291007055FlowTriever Catheter, XL10-1042016-09-15
00850291007147ClotTriever Catheter, Variable Length41-1022018-05-09
00850041730158LimFlow ARCAC-US-232024-04-19
00850041730011LimFlow ARCAC-US-212023-06-26
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
00810123710393ClotTriever BOLD Catheter42-1022025-04-09

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