FDA.reportPublic FDA data

Critiflo™

Primary DI
20884450323162
Brand
Critiflo™
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450323165
Catalog number
682060/A
Published
2019-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791844000CRITIFLO & CRITIFLO DOMEGould, Inc.1979-10-02KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450323162PackageGS110In Commercial Distribution
10884450323165PrimaryGS10
00884450323168Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445032316220884450323162
1088445032316510884450323165
00884450323168008844503231688844503231680884450323168

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595138793
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884450321031Exacta™10884450321031680124/A2021-02-16
10884450321048Exacta™10884450321048680126/A2019-05-28
10884450321055Exacta™10884450321055680128/A2019-06-03
10884450321062Exacta™10884450321062680140/A2019-07-05
10884450389994Exacta™10884450389994680132/A2019-09-04
00886333610006SECALON T 18G/1.25 X 90MM MULT=25/2506810006810002016-09-24
00886333610020SECALON T 16G/1.70 X 130MM MULT=25/2506810026810022016-09-30
00886333610044SECALON T 16G/1.70 X 160MM MULT=25/2506810046810042016-09-23
00886333616121CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816126816122016-09-24
00886333616145CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816146816142016-09-24
00886333616152CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816156816152016-09-24
00886333616169CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816166816162016-09-24
00886333616176CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816176816172016-09-24
00886333616183CAREFLOW(TM) 3 LUMEN 5FR X 100MM6816186816182016-09-24
00886333616190CAREFLOW(TM) 2 LUMEN 5FR X 60MM6816196816192016-09-24
00886333616206CAREFLOW(TM) 3 LUMEN 5FR X 60MM6816206816202016-09-24
00886333616220CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816226816222016-09-24
00886333616237CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816236816232016-09-24
00886333616244CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816246816242016-09-24
00886333616251CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816256816252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00810123710430ClotTriever SheathInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
00850291007222Protrieve SheathInari Medical, Inc.KRA2023-03-20
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22