EKM INFLATION DEVICE 194100

GUDID 20886333207613

EKM INFLATION DEVICE

ARGON MEDICAL DEVICES, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use
Primary Device ID20886333207613
NIH Device Record Key89a1a663-5dff-4bb7-a282-a3c0f48d9602
Commercial Distribution StatusIn Commercial Distribution
Brand NameEKM INFLATION DEVICE
Version Model Number194100
Catalog Number194100
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100886333207619 [Primary]
GS120886333207613 [Package]
Contains: 00886333207619
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAVSyringe, Balloon Inflation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
Device Publish Date2016-09-21

On-Brand Devices [EKM INFLATION DEVICE]

20886333207620EKM INFLATION DEVICE
20886333207613EKM INFLATION DEVICE

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