RAPID FGS-0472

GUDID 07290101363477

RT SW kit, v8.0 WW

Given Imaging, Inc.

Video capsule endoscopy system
Primary Device ID07290101363477
NIH Device Record Key04392dfa-cc5b-4875-b575-15b86ef10860
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAPID
Version Model NumberFGS-0472
Catalog NumberFGS-0472
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 Batchfalse
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
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Emailcovidien.udi@covidien.com
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Emailcovidien.udi@covidien.com
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Emailcovidien.udi@covidien.com
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Emailcovidien.udi@covidien.com
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Emailcovidien.udi@covidien.com
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Emailcovidien.udi@covidien.com
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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;
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;
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
GS107290101363477 [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 [RAPID]

07290101365013SW kit, v8.0 SCA WS
07290101365006SW upgrade, v8.0 SCA
07290101364467WS, Dell T3400, OUS RFB
07290101364207WS, Dell T3400, SCA
07290101364184WS, Dell T3400, US
07290101363477RT SW kit, v8.0 WW
07290101362784Access SW kit, v7.0 WS
07290101362265Access SW kit, v7.0
07290101362234SW upgrade, v7.0

Trademark Results [RAPID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAPID
RAPID
98395595 not registered Live/Pending
PMRAC, LLC
2024-02-07
RAPID
RAPID
98080546 not registered Live/Pending
Urban Gorilla, Inc.
2023-07-11
RAPID
RAPID
97716730 not registered Live/Pending
Aevumed, Inc.
2022-12-14
RAPID
RAPID
97602817 not registered Live/Pending
Adaptive Phage Therapeutics, Inc.
2022-09-22
RAPID
RAPID
97363635 not registered Live/Pending
Adaptive Phage Therapeutics, Inc.
2022-04-14
RAPID
RAPID
97107519 not registered Live/Pending
Informatix, Inc.
2021-11-03
RAPID
RAPID
97107509 not registered Live/Pending
Informatix, Inc.
2021-11-03
RAPID
RAPID
97074116 not registered Live/Pending
Adaptive Phage Therapeutics, Inc.
2021-10-14
RAPID
RAPID
97074095 not registered Live/Pending
Adaptive Phage Therapeutics, Inc.
2021-10-14
RAPID
RAPID
90760783 not registered Live/Pending
Thomson Reuters Special Services LLC
2021-06-08
RAPID
RAPID
90588628 not registered Live/Pending
Biolase, Inc.
2021-03-18
RAPID
RAPID
90565160 not registered Live/Pending
XL Parts LLC
2021-03-08

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