Safety MST Accessory Kit 384823

GUDID 20886333210064

Safety MST Accessory Kit 18GA (4Fr)

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20886333210064
NIH Device Record Keyc8479ece-0616-4c84-93ed-1e2993ee9a84
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafety MST Accessory Kit
Version Model Number384823
Catalog Number384823
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 Latextrue
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100886333210060 [Primary]
GS120886333210064 [Package]
Contains: 00886333210060
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

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 Date2016-09-21

On-Brand Devices [Safety MST Accessory Kit]

20886333210071Safety MST Accessory Kit 16GA (5Fr)
20886333210064Safety MST Accessory Kit 18GA (4Fr)
20886333210057Safety MST Accessory Kit 20GA (3Fr)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.