ESR STAT 6 ESR STAT 6

GUDID 00868556000208

Airscan, Inc.

Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 00868556000208
• NIH Device Record Key: 262868fa-437f-4726-9d7d-0161f6d8c925
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESR STAT 6
• Version Model Number: ESR STAT 6
• Catalog Number: ESR STAT 6
• Company DUNS: 807613476
• Company Name: Airscan, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00868556000208 [Primary]

FDA Product Code

• GKB: DEVICE, AUTOMATED SEDIMENTATION RATE

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: 2024-06-12
• Device Publish Date: 2024-06-04

Devices Manufactured by Airscan, Inc.

• 00868556000208 - ESR STAT 6: 2024-06-12
• 00868556000208 - ESR STAT 6: 2024-06-12
• 00868556000215 - HemaTechnologies ESR Control: 2024-06-12
• 00868556000222 - E-Z Safe Tubes: 2024-06-12
• 00868556000239 - HemaTechnologies ESR Control: 2024-06-12
• 00868556000246 - HemaTechnologies ESR Control: 2024-06-12
• 00868556000253 - HemaTechnologies ESR Control: 2024-06-12