WarmTouch 5030880

GUDID 10884521061804

Lower Body Blanket

Covidien LP

Circulating-air whole-body heating/cooling system pad, single-use, non-sterile Circulating-air whole-body heating/cooling system pad, single-use, non-sterile Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use

• Primary Device ID: 10884521061804
• NIH Device Record Key: c0c774cc-236c-4a17-9190-46a1e0002c3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WarmTouch
• Version Model Number: 5030880
• Catalog Number: 5030880
• 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: 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
• 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 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521061804 [Package]; Contains: 20884521061801; Package: CASE [12 Units]; In Commercial Distribution
GS1	20884521061801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913016

FDA Product Code

• DWJ: System, thermal regulating

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [WarmTouch]

• 10884521063198: Upper Body Blanket
• 10884521061804: Lower Body Blanket
• 10884521061798: Full-Body /Multi Access Blanket
• 10884521061514: Pediatric Surgical Blanket
• 10884521061378: Cardiac Blanket
• 10884521084599: Patient Warming System, Patient Warming Unit Hose Assembly (5200/5800)
• 10884521084568: Patient Warming System, Patient Warming Unit One Clip Nozzle
• 10884521141100: Convective Warming Unit
• 10884521190672: Convective Warming Unit Reconditioned
• 10884521817517: Convective Warming Unit Reconditioned
• 10884521084612: Patient Warming System, Patient Warming Unit Power cord (5200)
• 10884521169227: Convective Warming Unit Refurbished
• 10884521817524: Convective Warming Unit
• 20884521141114: Surgical Access Blanket
• 20884521141121: Torso Blanket
• 30884521061365: Pediatric Blanket