NICE

GUDID 00862103000307

Cold + Compression Therapy Unit

NICE RECOVERY SYSTEMS LLC

Circulating-fluid thermal therapy system pack, reusable

• Primary Device ID: 00862103000307
• NIH Device Record Key: e3aa9483-f87b-4215-ab41-0902e5a038f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICE
• Version Model Number: NICE1
• Company DUNS: 080284273
• Company Name: NICE RECOVERY SYSTEMS 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00862103000307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143197

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15