Prager Ext Set B1263 011B1263

GUDID B360011B12632

Replacement Part

ESI CORPORATION

Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive
Primary Device IDB360011B12632
NIH Device Record Keyd824b709-1cd3-4d50-9299-d37efcff3ade
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrager Ext Set B1263
Version Model Number011B1263
Catalog Number011B1263
Company DUNS829391734
Company NameESI CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com

Device Dimensions

Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB360011B12630 [Primary]
HIBCCB360011B12631 [Package]
Contains: B360011B12630
Package: BOX [4 Units]
In Commercial Distribution
HIBCCB360011B12632 [Package]
Contains: B360011B12630
Package: BOX [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMGStopcock, I.V. Set

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-24

Devices Manufactured by ESI CORPORATION

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B360011B12632 - Prager Ext Set B12632019-12-11Replacement Part
B360011B12632 - Prager Ext Set B12632019-12-11 Replacement Part
B360KF100 - Kera-Flow2019-09-18 Eye Irrigation Device
B360CS2001 - ClearScan®2018-07-06 ClearScan
B360P1000 - Prager Shell®2018-07-06 Accutome / MicroMedical
B360P100AS0 - Prager Shell®2018-07-06 Accutome Probe, Auto Stop
B360P1010 - Prager Shell®2018-07-06 For DGH 2009 and earlier
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