Bair Hugger™ 54200

GUDID 30608223542003

3M™ Bair Hugger® Torso Blanket, Dual Port, 10 Per Case 54200

3M COMPANY

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 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: 30608223542003
• NIH Device Record Key: 8f283738-b6f8-4e4c-9c70-62ad9203c312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bair Hugger™
• Version Model Number: 54200
• Catalog Number: 54200
• Company DUNS: 830016148
• Company Name: 3M COMPANY
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608223542002 [Unit of Use]
GS1	30608223542003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060865

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 [Bair Hugger™]

• 00608223795002: 3M™ Bair Hugger® Patient Warming Unit, Model 795, 120V-ENG-E, Refurbished 79500
• 00608223775332: 3M™ Bair Hugger® Patient Warming Unit, Model 775, 120V-ENG-E 77533
• 00608223775004: 3M™ Bair Hugger® Patient Warming Unit, Model 775, 120V-ENG-E 77500
• 00608223221105: 3M™ Bair-Hugger® Temperature Test Unit 22110
• 00707387782160: 3M™ Bair Hugger™ Temperature Monitoring Control Unit, 120V-ENG-E, 1 each, 37000
• 00707387775995: 3M™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, Spacelabs™ Compatible, 1 each, 9013
• 00707387775988: 3M™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, Phillips™ Mindray™ Compatible, 1
• 00707387775971: 3M™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, GE™ Compatible, 1 each, 90131
• 00707387775964: 3M™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, Draeger™ Compatible, 1 each, 90132
• 00707387775865: 3M™ Bair Hugger™ Temperature Monitoring Cable, 3.5-3mm, 1 each, 90108
• 00707387775858: 3M™ Bair Hugger™ Temperature Monitoring Cable, 3.5-6mm, 1 each, 90107
• 00707387775810: 3M™ Bair Hugger™ Temperature Monitoring Control Unit, 120V-ENG-E, 1 each, 37000
• 00707387775773: 3M™ Bair Hugger™ Temperature Test Unit, Model 500 and 700, 1 each, 22110
• 00707387775681: 3M™ Bair Hugger™ Temperature Management Unit, 120V-ENG-E, Refurbished, 1 each, 79500
• 00707387775629: 3M™ Bair Hugger™ Temperature Management Unit, 120V-ENG-E, Military Kit, 1 each, 77533
• 00707387775322: 3M™ Bair Hugger™ Temperature Management Unit, 120V-ENG-E, 1 each, 77500
• 00707387774905: 3M™ Bair Hugger™ Patient Adjustable Warming Unit, 120V-ENG-E, 1 each, 87500
• 00707387774899: 3M™ Bair Hugger™ Calibration Test Kit, Patient Adjustable Warming Unit, 1 each, 90055
• 00707387774691: 3M™ Bair Hugger™ Patient Adjustable Warming Unit, 120V-ENG-E, Refurbished, 1 each, 89500
• 50707387782219: 3M™ Bair Hugger™ Multi-Position Upper Body Blanket, 10 per case, 62200
• 50707387775808: 3M™ Bair Hugger™ Temperature Monitoring Sensor, 25 per case, 36000
• 50707387775242: 3M™ Warming Blanket, Torso, 10 per case, 44068
• 50707387775235: 3M™ Warming Blanket, Lower Body, 10 per case, 42568
• 50707387775228: 3M™ Warming Blanket, Upper Body, 10 per case, 42268
• 50707387775211: 3M™ Warming Blanket, Full Body, 10 per case, 40068
• 50707387775143: 3M™ Bair Hugger™ Sterile Cardiac Access Blanket, 5 per case, 64500
• 50707387775136: 3M™ Bair Hugger™ Sterile Full Access Underbody Blanket, 5 per case, 63700
• 50707387775129: 3M™ Bair Hugger™ Full Access Underbody Blanket, 10 per case, 63500
• 50707387775112: 3M™ Bair Hugger™ Sterile Cardiac Blanket, 5 per case, 63000
• 50707387775105: 3M™ Bair Hugger™ Full Body Surgical Blanket, 10 per case, 61000
• 50707387775099: 3M™ Bair Hugger™ Lithotomy Underbody Blanket, 10 per case, 58501
• 50707387775082: 3M™ Bair Hugger™ Spinal Underbody Blanket, 5 per case, 57501
• 50707387775075: 3M™ Bair Hugger™ Surgical Access Blanket, 10 per case, 57000
• 50707387775068: 3M™ Bair Hugger™ Cath Lab Blanket, 10 per case, 56000
• 50707387775051: 3M™ Bair Hugger™ Pediatric Underbody Blanket, 10 per case, 55501
• 50707387775044: 3M™ Bair Hugger™ Pediatric Underbody Blanket, Large, 10 per case, 55000
• 50707387775037: 3M™ Bair Hugger™ Adult Underbody Blanket, 10 per case, 54500
• 50707387775020: 3M™ Bair Hugger™ Dual Port Torso Blanket, 10 per case, 54200
• 50707387775013: 3M™ Bair Hugger™ Torso Blanket, 10 per case, 54000
• 50707387775006: 3M™ Bair Hugger™ Lower Body Blanket, Small, 10 per case, 53700
• 50707387774993: 3M™ Bair Hugger™ Pediatric Blanket, Long, 10 per case, 53000
• 50707387774986: 3M™ Bair Hugger™ Lower Body Blanket, 10 per case, 52500
• 50707387774979: 3M™ Bair Hugger™ Upper Body Blanket, X-Large, 10 per case, 52301
• 50707387774962: 3M™ Bair Hugger™ Upper Body Blanket, 10 per case, 52200
• 50707387774955: 3M™ Bair Hugger™ Multi-Access Blanket, 10 per case, 31500
• 50707387774948: 3M™ Bair Hugger™ Pediatric Blanket, 10 per case, 31000
• 50707387774931: 3M™ Bair Hugger™ Chest Access Blanket, 10 per case, 30500
• 50707387774924: 3M™ Bair Hugger™ Full Body Blanket, 10 per case, 30000
• 50707387774917: 3M™ Bair Hugger™ Outpatient Blanket, 10 per case, 11101
• 50707387774900: 3M™ Bair Hugger™ Outpatient Blanket with Booties, 10 per case, 11000