One Degree Medical

GUDID 00860003583050

3.8L Capacity Fluid Warming Unit - ODM-3038

ONE DEGREE MEDICAL HOLDINGS, LLC

Surgical fluid heating plate

• Primary Device ID: 00860003583050
• NIH Device Record Key: 401425f7-aecb-4cdc-a7a7-567c5c034390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Degree Medical
• Version Model Number: ODM-3038
• Company DUNS: 065180232
• Company Name: ONE DEGREE MEDICAL HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003583050 [Primary]

FDA Product Code

• LHC: Warmer, Irrigation Solution

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: 2021-03-04
• Device Publish Date: 2021-02-24

On-Brand Devices [One Degree Medical]

• 10860003583019: Fluid Warmer Drape 44" x 66" (ODM-1100)
• 10860003583002: Fluid Warmer Drape 44" x 44" (ODM-1000)
• 10860003583033: Fluid Warmer Drape 44" x 60" (ODM-2066)
• 10860003583026: Fluid Warmer Drape 44" x 60" (ODM-2038)
• 00860003583067: Fluid Warming System Stand - ODM-STN01
• 00860003583050: 3.8L Capacity Fluid Warming Unit - ODM-3038
• 00860003583043: 6.6L Capacity Fluid Warming Unit - ODM-3066