Kozee

GUDID 18973920006973

Extra Large Warming Suit

Sourcemark, Llc.

Circulating-air whole-body heating system control unit

• Primary Device ID: 18973920006973
• NIH Device Record Key: 5b3fae0a-d43e-45a0-a0f0-1d72af6c89bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kozee
• Version Model Number: M21304
• Company DUNS: 121225812
• Company Name: Sourcemark, Llc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08973920006723 [Primary]
GS1	18973920006973 [Package]; Contains: 08973920006723; Package: Box [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190221

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: 2020-02-04
• Device Publish Date: 2020-01-27

On-Brand Devices [Kozee]

• 18973920006973: Extra Large Warming Suit
• 18973920006966: Large Warming Suit
• 18973920006959: Medium Warming Suit
• 18973920006942: Small Warming Suit
• 18973920006935: Lithotomy&Orthopedic Under Body Warming Blanket
• 08973920006679: Infant Under Body Warming Blanket
• 18973920006911: Full Body & Under Body Warming Blanket
• 18973920006904: XL Upper Body Warming Blanket Intraoperative
• 18973920006898: Cardiac Access Warming Blanket Other
• 18973920006881: Surgical Access Warming Blanket Other
• 08973920006624: Cath Lab Warming Blanket Other
• 18973920006867: Long Warming Blanket
• 18973920006850: Lower Body Warming Blanket
• 18973920006843: Spinal Under Body Warming Blanket
• 18973920006836: Large Under Body Warming Blanket
• 18973920006829: Full Body Surgical Warming Blanket Postoperative
• 18973920006812: Full Body Warming Blanket Postoperative
• 18973920006805: Full Access Under Body Warming Blanket
• 08973920006549: Under Body Warming Blanket
• 18973920006782: Adult Full Body Warming Blanket Postoperative
• 18973920006775: Upper Body Warming Blanket Intraoperative
• 18973920006768: Lower Body Warming Blanket Intraoperative
• 18973920006751: Torso Warming Blanket Intraoperative
• 08973920006730: Warming Unit