Mul-T-Blanket HP7010

GUDID 07613327348873

STRYKER CORPORATION

Circulating-fluid whole-body heating/cooling system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable

• Primary Device ID: 07613327348873
• NIH Device Record Key: 8ddd79d9-8498-4db9-8819-e8d103efb430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mul-T-Blanket
• Version Model Number: HP7010
• Catalog Number: HP7010
• Company DUNS: 078470558
• Company Name: STRYKER CORPORATION
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327348873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100585

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 [Mul-T-Blanket]

• 07613327348873: HP7010
• 57613327175351: 8001-061-612
• 57613327175122: 8001-061-610
• 07613327175110: 8001-061-702
• 07613327175097: 8001-061-701
• 57613327175061: 8001-061-810
• 57613327175054: 8001-061-812