One Degree Medical

GUDID 10860003583019

Fluid Warmer Drape 44" x 66" (ODM-1100)

ONE DEGREE MEDICAL HOLDINGS, LLC

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• Primary Device ID: 10860003583019
• NIH Device Record Key: 1e0e26b9-ca16-4a44-bd97-131d03a9ce53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Degree Medical
• Version Model Number: ODM-1100
• 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: 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

Customer Support Contacts

• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com
• Phone: 762-354-2048
• Email: customerservice@onedegreemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003583012 [Primary]
GS1	10860003583019 [Package]; Contains: 00860003583012; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

[10860003583019]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-23
• Device Publish Date: 2020-06-15

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