FDA.reportPublic FDA data

FlowStasis

Primary DI
00850291007239
Brand
FlowStasis
Company
Inari Medical, Inc.
Model
70-101
Device description
Flowstatsis Suture Retention Device, 3-count
Published
2021-03-22
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
KGSRetention Device, Suture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850291007239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850291007239008502910072398502910072390850291007239

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion filterA sterile, microporous device inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
19496008433info@inarimedical.com

Regulatory Flags#

DUNS number
076827459
Device count
1
Premarket exempt
true
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
0081012371048524 Fr Evacuation System131-102 / AS-012292024-10-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011629412V-CloseDRS Vascular, Inc.KGS2026-03-09
10860011629419V-CloseDRS Vascular, Inc.KGS2026-03-09
00810178880652ViveVIVE HEALTH LLCKGS2026-02-05
00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
00850012846680SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007140LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00860007834233SUTUREGARD(R) Classic Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
00860007834240SUTUREGARD(R) Hammerhead(TM) Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
10888277381766MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
10884450786199Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00860011629405Q-StopDRS Vascular, Inc.KGS2024-05-23
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
00630094199818Bioseal Inc.BIOSEALKGS2023-12-19
00630094199832Bioseal Inc.BIOSEALKGS2023-12-19
00630094199863Bioseal Inc.BIOSEALKGS2023-12-19
00630094199870Bioseal Inc.BIOSEALKGS2023-12-19
00630094199894Bioseal Inc.BIOSEALKGS2023-12-19
10630094199815Bioseal Inc.BIOSEALKGS2023-12-19
10630094199839Bioseal Inc.BIOSEALKGS2023-12-19
10630094199860Bioseal Inc.BIOSEALKGS2023-12-19
10630094199877Bioseal Inc.BIOSEALKGS2023-12-19
10630094199891Bioseal Inc.BIOSEALKGS2023-12-19
00630094199719Bioseal Inc.BIOSEALKGS2023-12-12
00630094199733Bioseal Inc.BIOSEALKGS2023-12-12
00630094199757Bioseal Inc.BIOSEALKGS2023-12-12
00630094199788Bioseal Inc.BIOSEALKGS2023-12-12