Aquilo Sports

GUDID 00850009827333

Aquilo Sports L.L.C.

Circulating-fluid localized thermal/compression therapy system control unit

• Primary Device ID: 00850009827333
• NIH Device Record Key: 4d8de5de-8c5b-4938-852d-d5380a15cd91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquilo Sports
• Version Model Number: CCT1500 System
• Company DUNS: 080077503
• Company Name: Aquilo Sports L.L.C.
• 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: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850009827333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223164

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2024-07-24
• Device Publish Date: 2024-07-16