Insitu - ONTRAC PTCA Endoflator 21000-30

GUDID 00856877002582

Inflation Device: 20mL, 30atm

ATRION MEDICAL PRODUCTS, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use
Primary Device ID00856877002582
NIH Device Record Key016e7910-12dc-4c96-bad4-887a18f3fd9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsitu - ONTRAC PTCA Endoflator
Version Model NumberQL® 2030
Catalog Number21000-30
Company DUNS047571476
Company NameATRION MEDICAL PRODUCTS, 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

Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com
Phone+1(800)343-9334
Emailinfo@atrionmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856877002582 [Primary]

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 Number4
Public Version Date2020-05-06
Device Publish Date2016-09-19

Devices Manufactured by ATRION MEDICAL PRODUCTS, INC.

00856877002728 - QL Disposable Inflation Device2022-11-15 Inflation Device: 40mL, 15atm
00856877002711 - PAVmed™ Inflation Device2021-12-07 Inflation Device Atrion Part Number 96519: 40mL, 15atm
00856877002667 - QL Locking Syringe Device2021-07-01 Locking Syringe Device Atrion Part Number 96503: 38mL
00856877002650 - QL Disposable Inflation Device2021-02-04 Inflation Device Atrion Part Number 96515: 20mL, 30atm
00856877002445 - Boston Scientific Encore 40 Inflation Device2020-07-31 Inflation Device: 25mL, 40atm
00856877002636 - SIS MEDICAL 40atm Inflation Device2020-05-18 Inflation Device: 25mL, 40atm
00856877002643 - SIS MEDICAL 55atm Inflation Device2020-05-18 Inflation Device: 14mL, 55atm
H965459830 - angiodynamics NAMIC™ Disposable Inflation Device2020-05-06 Inflation Device: 20mL, 30atm
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