Athelas One

GUDID 00860001013221

Athelas, Inc.

Laboratory analyser cuvette IVD, single-use

• Primary Device ID: 00860001013221
• NIH Device Record Key: 59a5652e-379a-4446-8fc8-150acea704bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athelas One
• Version Model Number: 850-00002-00
• Company DUNS: 080636378
• Company Name: Athelas, Inc.
• Device Count: 50
• 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: false
• Expiration Date: true
• 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	00860001013214 [Unit of Use]
GS1	00860001013221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181288

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-11
• Device Publish Date: 2019-03-26

On-Brand Devices [Athelas One]

• 00860001013238: 850-00001-00
• 00860001013221: 850-00002-00