16 Fr Evacuation System

Primary DI
00810123710478
Brand
16 Fr Evacuation System
Company
Inari Medical, Inc.
Model
131-101 / AS-01226
Device description
16 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

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
00810123710478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123710478008101237104788101237104780810123710478

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
00850041730134LimFlow VectorVT-US-232024-04-12
00850041730028LimFlow VectorVT-US-212023-06-26
00850041730141LimFlow V-CeiverVC-US-232024-03-09
00850041730165LimFlow Crossing Stent GraftRGS-35060-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
00810123710140ClotTriever Catheter40-10240-1022024-04-17
00850291007475Triever LA Transseptal Sheath121-101121-1012024-04-15
00810123710058ClotTriever SheathAS-0126150-1012023-12-15
00810123710430ClotTriever Sheath51-10151-1012023-12-15
00850291007123ClotTriever Sheath51-1012021-03-22
00850041730158LimFlow ARCAC-US-23AC-US-232024-04-19
00850291007697Large Bore 60 cc Syringe99-10299-1022024-12-20
00810123710577Artix Thin-Walled Sheath30-1042024-11-11
00810123710560Artix Thin-Walled Sheath30-10330-1032024-11-07
00850291007406VenaCore Thrombectomy Catheter46-10146-1012024-03-27
00850291007420FlowStasis Single-Pack70-10370-1032023-07-19
00850291007369InThrill Sheath53-10153-1012023-07-18
00850291007246FlowSaver80-10180-1012023-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081012371048524 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