Athelas One

GUDID 00860001013238

Athelas, Inc.

Haematological cell analyser IVD, automated

• Primary Device ID: 00860001013238
• NIH Device Record Key: f88293f3-58bf-49d0-aa9e-d234bfc37192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athelas One
• Version Model Number: 850-00001-00
• Company DUNS: 080636378
• Company Name: Athelas, Inc.
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001013238 [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: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-03-26

On-Brand Devices [Athelas One]

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