Paramount Mini GPS PMB4-5-14-80

GUDID 00821684006382

Balloon-Expandable Biliary Stent System

Covidien LP

Bare-metal biliary stent
Primary Device ID00821684006382
NIH Device Record Keya5e5ae89-f913-4982-9fa2-c78b285eb0fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameParamount Mini GPS
Version Model NumberPMB4-5-14-80
Catalog NumberPMB4-5-14-80
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

Device Size Text, specify0
Device Size Text, specify0
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Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0
Outer Diameter5 Millimeter
Length14 Millimeter
Catheter Gauge5 French
Device Size Text, specify0

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
GS100821684006382 [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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