ManoScan 9012P1412

GUDID 05704736001311

8ch Anorectal SUM 0,0.5

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 Manometric gastrointestinal motility analysis system

• Primary Device ID: 05704736001311
• NIH Device Record Key: 04ce8be0-1850-4e1a-8635-e258996b95ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManoScan
• Version Model Number: 9012P1412
• Catalog Number: 9012P1412
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704736001311 [Primary]
GS1	10884521742710 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032138

FDA Product Code

• KLA: MONITOR, ESOPHAGEAL MOTILITY, AND TUBE

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: 2017-05-17

On-Brand Devices [ManoScan]

• 07290110360368: GIFD WS PC, 3050 Win 10 with SW
• 07290110360344: GIFD laptop, 5480 Win 10 with SW
• 07290101366973: Assy, ManoScan Cart
• 07290101366188: HRM/CLT WS, Dell 3020 W7
• 07290101366102: CLT v3.0 software upgrade
• 07290101365945: v3.0 software kit upgrade
• 07290101365921: v3.0 software kit
• 07290101365914: Notebook, Dell E6440 Win 7
• 07290101365877: Dell 3020 Win XP GT
• 07290101365860: Dell 3020 Win 7
• 07290101365679: A550 Manometry Module
• 07290101365600: Balloon, ARM 150cc, 10-pack
• 07290101365594: Balloon, ARM 600cc, 10-pack
• 07290101365587: Balloon, ARM 400cc, 10-pack
• 07290101365433: ESOZ accessory kit,PWS
• 07290101365426: ESO accessory kit, PWS
• 07290101365402: PDU, holding plate & top case mount
• 07290101364290: V A400 Module
• 07290101363958: 4279GIV CART CAL CHAMBER RIGIDAR HDMVS
• 07290101363736: SSI Cal Chamber Mount
• 07290101363729: Non SSI Cal Chamber Mount 3DAR
• 07290101363712: Cal Chamber Mount MVS
• 07290101363705: Cal Chamber Mount 3DAR
• 07290101363590: 3D A300 Module, RFB
• 07290101363583: A120 Module
• 07290101363545: Z A200 Module, RFB
• 07290101363521: A120 Module
• 07290101362685: 3D A300 Module
• 07290101362678: Z A200 Module
• 05704736001328: SUM 8ch radial w/balloon,
• 05704736001311: 8ch Anorectal SUM 0,0.5
• 05704736001304: 4 ch Anorectal Cat. Sil. w/Bal,
• 05704736001298: Single use Catheter 4 ch w/o central lum
• 05704736001281: 4ch 7.5mm sp Esophageal
• 05704736001274: 8ch Anorectal SinUse Man,
• 05704736001267: 8ch Vector Vol. SinUse Man
• 05704736001250: 4ch Anorectal SinUse Man.cath,0,1,2,3-ba
• 05704736001243: 8ch Esophageal Sinuse Ma,
• 05704736001236: 8ch Esophageal Sinuse Ma,
• 05704736001229: Esophageal SinUse Man. Cath.,0,5,10,15 c
• 04260167483719: MSS-4581-3D MANOSHIELD 3DAR - BOX 10
• 04260167483597: ESO Catheter, RFG
• 04260167482637: ESO 3D Catheter
• 04260167482545: AR Catheter, Small
• 04260167482538: AR 3D Probe
• 04260167482507: ESO Z Catheter
• 04260167482491: ESO With Extended Tip
• 04260167482262: Assy, Retail Box of 20, ManoShield SD
• 04260167482248: Assy, Retail Box of 10, ManoShield AR
• 04260167482200: Assy, Retail Box of 20, ManoShield EG