LB Medical Disposable Inflation Device 96420

GUDID 00856877002339

Inflation Device: 10mL, 20atm

ATRION MEDICAL PRODUCTS, INC.

Catheter/overtube balloon inflator, single-use
Primary Device ID00856877002339
NIH Device Record Keyf6a23bed-60e8-4401-b302-764191a1c3fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameLB Medical Disposable Inflation Device
Version Model NumberQL® 1020
Catalog Number96420
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
GS100856877002339 [Primary]

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.

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00856877002759 - QL Disposable Inflation Device2025-05-26 Inflation Device Atrion Part Number 96529: 25mL, 30atm
00856877002766 - Atrion QL4515 Inflation Device2025-05-26 Inflation Device Atrion Part Number 96530: 45mL, 15atm
00856877002773 - Atrion QL4515 Inflation Device2025-05-26 Inflation Device Atrion Part Number 96531: 45mL, 15atm
00856877002704 - Atrion QL4515 Inflation Device2024-08-14 Inflation Device Atrion Part Number 96518: 45mL, 15atm
00856877002735 - QL Inflation Device2024-08-14 Inflation Device: 60mL, 20atm
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

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