angiodynamics NAMIC™ Disposable Inflation Device H965459830

GUDID H965459830

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
Primary Device IDH965459830
NIH Device Record Key45edfc34-eb94-4a10-ad92-c876cdd4ed7f
Commercial Distribution StatusIn Commercial Distribution
Brand Nameangiodynamics NAMIC™ Disposable Inflation Device
Version Model NumberQL® 2030PR
Catalog NumberH965459830
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH965459830 [Primary]
HIBCCH965459831 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KOEDilator, Urethral

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 Device2020-05-06Inflation Device: 20mL, 30atm
H965459830 - angiodynamics NAMIC™ Disposable Inflation Device2020-05-06 Inflation Device: 20mL, 30atm
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