HemaTechnologies ESR Control ESRC20016

GUDID 00868556000253

Airscan, Inc.

Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control

• Primary Device ID: 00868556000253
• NIH Device Record Key: 03a806a1-070c-44fc-9615-e82694a5cd62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemaTechnologies ESR Control
• Version Model Number: ESRC20016
• Catalog Number: ESRC20016
• Company DUNS: 807613476
• Company Name: Airscan, 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868556000253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991876

FDA Product Code

• JPK: Mixture, hematology quality control

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

On-Brand Devices [HemaTechnologies ESR Control]

• 00868556000253: ESRC20016
• 00868556000246: ESRC20014
• 00868556000239: ESRC20012
• 00868556000215: ESRC20002