FDA.report

CAREFLOW(TM) 1 LUMEN 2.5FR X 200MM

Primary DI
50886333616331
Brand
CAREFLOW(TM) 1 LUMEN 2.5FR X 200MM
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
681633
Catalog number
681633
Device description
Kits Contents : Catheter 2.5FR OD 0.9mmx200mm; straight guidewire OD 0.46mmx450mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD1.0mmx45mm, Floswitch(TM)
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

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50886333616331PackageGS1100In Commercial Distribution
00886333616336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633361633150886333616331
00886333616336008863336163368863336163360886333616336

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

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10884450330798Merit Medical®00884450330791684085/A2022-09-20
20884450321502Careflow™10884450321505681631/A2022-09-20
20884450387751Merit Medical®10884450387754682075/B2022-06-16
20884450385160Meritrans DTXPlus®10884450385163682034/B2022-06-08
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00884450323267Meritrans DTXPlus®10884450323264683019/A2022-03-04
20884450619289Meritrans DTXPlus®10884450619282689887/B2022-02-28
20884450619296Safedraw™10884450619299689844/B2022-02-28
20884450621152Safedraw™10884450621155689883/B2022-02-28
20884450371774Meritrans DTXPlus®10884450371777682012/B2022-02-18
10884450361037Merit Medical®00884450361030684061/A2022-01-19
20884450321885Careflow™10884450321888681718/A2022-01-10
10884450361013Merit Medical®00884450361016684045/A2020-11-13
20884450320901Critikit™10884450320904680000/A2018-01-30

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