KoZee Warming Blanket

GUDID 26951013002797

Jiangmen Dacheng Medical Equipment Co., Ltd.

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: 26951013002797
• NIH Device Record Key: fec67271-8932-4ac7-99b8-3061c8105d3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KoZee Warming Blanket
• Version Model Number: M21015
• Company DUNS: 548017546
• Company Name: Jiangmen Dacheng Medical Equipment Co., Ltd.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06951013002793 [Primary]
GS1	26951013002797 [Package]; Contains: 06951013002793; Package: Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231596

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

On-Brand Devices [KoZee Warming Blanket]

• 26951013002896: M21304
• 26951013002889: M21303
• 26951013002872: M21302
• 26951013002865: M21301
• 26951013002858: M21029
• 26951013002841: M21028
• 26951013002834: M21025
• 26951013002827: M21021
• 26951013002810: M21020
• 26951013002803: M21016
• 26951013002797: M21015
• 26951013002780: M21014
• 26951013002773: M21012
• 26951013002766: M21010
• 26951013002759: M21009
• 26951013002742: M21008
• 26951013002735: M21007
• 26951013002728: M21006
• 26951013002711: M21005
• 26951013002704: M21004
• 26951013002698: M21003
• 26951013002681: M21002
• 06951013002670: M21001