Mano Scan 800022

GUDID 07290101365754

ManoScan ESO Software

Covidien LP

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system

Primary Device ID	07290101365754
NIH Device Record Key	eb4a2aa1-1f41-4f65-ab34-65def8fdea1e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mano Scan
Version Model Number	800022
Catalog Number	800022
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
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	07290101365754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151086

FDA Product Code

NEZ	SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-11-08
Device Publish Date	2018-07-31

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