Paramount Mini GPS PMB8-7-14-80

GUDID 00821684006580

Balloon-Expandable Biliary Stent System

Covidien LP

Bare-metal biliary stent
Primary Device ID00821684006580
NIH Device Record Key7c99052a-0a0f-4595-b7d4-32bb07961ad3
Commercial Distribution StatusIn Commercial Distribution
Brand NameParamount Mini GPS
Version Model NumberPMB8-7-14-80
Catalog NumberPMB8-7-14-80
Company DUNS968903703
Company NameCovidien LP
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(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter7 Millimeter
Length14 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100821684006580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGECATHETER, BILIARY, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

On-Brand Devices [Paramount Mini GPS]

00821684006641Balloon-Expandable Biliary Stent System
00821684006634Balloon-Expandable Biliary Stent System
00821684006627Balloon-Expandable Biliary Stent System
00821684006610Balloon-Expandable Biliary Stent System
00821684006603Balloon-Expandable Biliary Stent System
00821684006597Balloon-Expandable Biliary Stent System
00821684006580Balloon-Expandable Biliary Stent System
00821684006573Balloon-Expandable Biliary Stent System
00821684006566Balloon-Expandable Biliary Stent System
00821684006467Balloon-Expandable Biliary Stent System
00821684006450Balloon-Expandable Biliary Stent System
00821684006443Balloon-Expandable Biliary Stent System
00821684006436Balloon-Expandable Biliary Stent System
00821684006429Balloon-Expandable Biliary Stent System
00821684006412Balloon-Expandable Biliary Stent System
00821684006405Balloon-Expandable Biliary Stent System
00821684006399Balloon-Expandable Biliary Stent System
00821684006382Balloon-Expandable Biliary Stent System

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