Boston Scientific Encore 40 Inflation Device 96505

GUDID 00856877002445

Inflation Device: 25mL, 40atm

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
Primary Device ID00856877002445
NIH Device Record Keyb228ed31-631e-4933-bf52-3eb2337ce099
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoston Scientific Encore 40 Inflation Device
Version Model NumberQL® 2540
Catalog Number96505
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]
GS100856877002445 [Primary]

FDA Product Code

MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
MAVSyringe, Balloon Inflation
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 Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by ATRION MEDICAL PRODUCTS, INC.

00856877002445 - Boston Scientific Encore 40 Inflation Device2020-07-31Inflation Device: 25mL, 40atm
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
10827002255712 - COOK Medical Sphere™ Inflation Device2020-05-06 Inflation Device: 20mL, 30atm
10827002310275 - COOK Medical Sphere™ Inflation Device2020-05-06 Inflation Device: 20mL, 30atm
10827002349039 - COOK Medical Sphere™ Inflation Device2020-05-06 Inflation Device: 60mL, 15atm
10827002462837 - COOK Medical Sphere™ Inflation Device2020-05-06 Inflation Device: 25mL, 15atm

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