Polygraf ID 9043G0133

GUDID 07290101363330

A500 Module

Given Imaging, Inc.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 07290101363330
• NIH Device Record Key: 36e0a225-6b01-4a2c-a9c3-6738e3e3573c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polygraf ID
• Version Model Number: 9043G0133
• Catalog Number: 9043G0133
• Company DUNS: 090073722
• Company Name: Given Imaging, Inc.
• 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 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101363330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014269

FDA Product Code

• MYE: SYSTEM,ELECTROGASTROGRAPHY(EGG)

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: 2016-09-24

Devices Manufactured by Given Imaging, Inc.

• 07290110361068 - GIFD: 2020-01-17 PillCam sensor belt, DR3 C2 SBC
• 04260167480954 - ManoScan: 2019-11-08 AR 3D Probe
• 04260167480961 - ManoScan: 2019-11-08 ESO Catheter, SD Regular
• 04260167482422 - ManoScan: 2019-11-08 ESO 3D Catheter
• 04260167482439 - ManoScan: 2019-11-08 ESO With Extended Tip
• 04260167482446 - ManoScan: 2019-11-08 ESO Z Catheter
• 04260167482453 - ManoScan: 2019-11-08 ESO Catheter, SD Small
• 04260167482460 - ManoScan: 2019-11-08 AR Catheter, Small