SIS MEDICAL 40atm Inflation Device 96346

GUDID 00856877002636

Inflation Device: 25mL, 40atm

ATRION MEDICAL PRODUCTS, INC.

Catheter/overtube balloon inflator, single-use
Primary Device ID00856877002636
NIH Device Record Key2938ca91-adb6-46c4-801c-2894e4c71a45
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIS MEDICAL 40atm Inflation Device
Version Model NumberQL® 2540
Catalog Number96346
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856877002636 [Primary]

FDA Product Code

MAVSyringe, Balloon Inflation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-18
Device Publish Date2020-05-08

Devices Manufactured by ATRION MEDICAL PRODUCTS, INC.

00856877002742 - QL Locking Syringe Device2025-05-26 Locking Syringe Device Atrion Part Number 96527: 38mL
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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