FDA.reportPublic FDA data

CAREFLOW(TM) 1 LUMEN 4FR X 60MM

Primary DI
00886333616244
Brand
CAREFLOW(TM) 1 LUMEN 4FR X 60MM
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
681624
Catalog number
681624
Device description
Kits Contents : Catheter 4FR OD 1.45mmx60mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Overneedle Introducer 20G OD1.07mmx45mm, Dilator 5FR OD 1.7mm ID 0.66mm & Syringe 5ml.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333616249PackageGS150In Commercial Distribution
00886333616244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633361624950886333616249
00886333616244008863336162448863336162440886333616244

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
595138793
Device count
1
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
00886333616251CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816256816252016-09-24
00886333616268CAREFLOW(TM) 2 LUMEN 4FR X 100MM6816266816262016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
10801902102901ARROWTELEFLEX INCORPORATEDFOZ2019-12-10
10801902130331ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130355ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130379ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902133004ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133028ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133042ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133066ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133080ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133240ARROWTELEFLEX INCORPORATEDFOZ2017-03-14
10801902133233ARROWTELEFLEX INCORPORATEDFOZ2017-03-08
10801902133127ARROWTELEFLEX INCORPORATEDFOZ2017-03-07
10801902132816ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902132823ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133097ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133103ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902131529ARROWTELEFLEX INCORPORATEDFOZ2017-02-17
10801902131512ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
10801902131567ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
00801741074769Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
00801741074783Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130935ARROWTELEFLEX INCORPORATEDFOZ2016-12-21