ManoView FGS-8031

GUDID 07290101369059

AR v3.0 Software Upgrade kit

Covidien LP

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Primary Device ID	07290101369059
NIH Device Record Key	61d16555-4b56-4f58-8e5c-1731a377aea3
Commercial Distribution Status	In Commercial Distribution
Brand Name	ManoView
Version Model Number	FGS-8031
Catalog Number	FGS-8031
Company DUNS	058614483
Company Name	Covidien LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com

Operating and Storage Conditions

Special Storage Condition, Specify

Between 0 and 0 *;

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101369059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151086

FDA Product Code

FFX	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-11-08
Device Publish Date	2017-07-20

On-Brand Devices [ManoView]

07290101369059	AR v3.0 Software Upgrade kit
07290101369042	ESO v3.0.1 SW Upgrade kit
07290101365938	CLT v3.0 software kit
07290101365785	AR v3.0 Software kit
07290101365778	v3.0.1 Software kit
07290101369578	ManoView ESO Software v3.3