FilteredFlo Warming Unit

GUDID 06951013002915

Jiangmen Dacheng Medical Equipment Co., Ltd.

Circulating-air whole-body heating system control unit

• Primary Device ID: 06951013002915
• NIH Device Record Key: 8e2c54ac-c4e4-4231-9db0-bcdc5f90a936
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilteredFlo Warming Unit
• Version Model Number: FF-507
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06951013002915 [Primary]

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: 2024-11-04
• Device Publish Date: 2024-10-27

Devices Manufactured by Jiangmen Dacheng Medical Equipment Co., Ltd.

• 06951013002915 - FilteredFlo Warming Unit: 2024-11-04
• 06951013002915 - FilteredFlo Warming Unit: 2024-11-04
• 06951013002670 - KoZee Warming Blanket: 2023-09-19
• 26951013002681 - KoZee Warming Blanket: 2023-09-19
• 26951013002698 - KoZee Warming Blanket: 2023-09-19
• 26951013002704 - KoZee Warming Blanket: 2023-09-19
• 26951013002711 - KoZee Warming Blanket: 2023-09-19
• 26951013002728 - KoZee Warming Blanket: 2023-09-19
• 26951013002735 - KoZee Warming Blanket: 2023-09-19