ManoScan 3886

GUDID 04260167482453

ESO Catheter, SD Small

Given Imaging, Inc.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 04260167482453
• NIH Device Record Key: b3ee9edc-dc61-4d85-b0aa-9f0fecb10d4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManoScan
• Version Model Number: 3886
• Catalog Number: 3886
• Company DUNS: 090073722
• Company Name: Given Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• 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
• 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
• 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 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260167482453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091070

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: 2016-09-24

On-Brand Devices [ManoScan]

• 07290101365709: accessory kit
• 07290101363699: A400 accessory kit
• 07290101363347: A510 Module
• 04260167482989: ESO Catheter, RFG
• 04260167482569: ESO Catheter
• 04260167482552: AR Catheter, Regular
• 04260167482521: ESO Catheter, SD Small
• 04260167482514: ESO Catheter, SD Regular
• 04260167482484: ESO Catheter
• 04260167482477: AR Catheter, Regular
• 04260167482460: AR Catheter, Small
• 04260167482453: ESO Catheter, SD Small
• 04260167482446: ESO Z Catheter
• 04260167482439: ESO With Extended Tip
• 04260167482422: ESO 3D Catheter
• 04260167480961: ESO Catheter, SD Regular
• 04260167480954: AR 3D Probe