PAC Kit/5 Catheter Introducer Kit 497402

GUDID 20886333214369

PAC Kit/5 Catheter Introducer Kit 6F

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20886333214369
NIH Device Record Keyc8b647b6-4ac5-438b-8f67-a640a4190443
Commercial Distribution StatusIn Commercial Distribution
Brand NamePAC Kit/5 Catheter Introducer Kit
Version Model Number497402
Catalog Number497402
Company DUNS140727624
Company NameARGON MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100886333214365 [Primary]
GS120886333214369 [Package]
Contains: 00886333214365
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

On-Brand Devices [PAC Kit/5 Catheter Introducer Kit]

20886333216394PAC Kit/5 Catheter Introducer Kit 8.5F
20886333216387PAC Kit/5 Catheter Introducer Kit 8F
20886333214383PAC Kit/5 Catheter Introducer Kit 8F
20886333214369PAC Kit/5 Catheter Introducer Kit 6F
20886333214352PAC Kit/5 Catheter Introducer Kit 5F

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