Pillcam FGS-0325

GUDID 07290101362845

sensor belt, DR2, SB

Given Imaging, Inc.

Video capsule endoscopy system
Primary Device ID07290101362845
NIH Device Record Key7755f14f-8e50-474f-b19c-a0481fd83190
Commercial Distribution StatusIn Commercial Distribution
Brand NamePillcam
Version Model NumberFGS-0325
Catalog NumberFGS-0325
Company DUNS090073722
Company NameGiven Imaging, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile

Device Identifiers

Device Issuing AgencyDevice ID
GS107290101362845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEZSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Pillcam]

07290101365686sensor array, DR2 8-lead
07290101364146sensor belt, DR3 SB3
07290101363231recorder accessories DR2 sm
07290101363200sensor array, DR2 3-lead
07290101363194sensor array, DR2 8-lead
07290101362845sensor belt, DR2, SB

Trademark Results [Pillcam]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PILLCAM
PILLCAM
98120065 not registered Live/Pending
Given Imaging Ltd.
2023-08-07
PILLCAM
PILLCAM
87130172 5628324 Live/Registered
Given Imaging Ltd.
2016-08-08
PILLCAM
PILLCAM
78450962 3220545 Live/Registered
GIVEN IMAGING LTD.
2004-07-15
PILLCAM
PILLCAM
78083692 not registered Dead/Abandoned
Given Imagaing Ltd.
2001-09-13

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