E-Z Safe Tubes ESRK10001-S

GUDID 00868556000222

Airscan, Inc.

Capillary blood collection tube IVD, no additive

• Primary Device ID: 00868556000222
• NIH Device Record Key: bbf44175-d4eb-4a41-9f92-a63c64e1ea24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Z Safe Tubes
• Version Model Number: ESRK10001-S
• Catalog Number: ESRK10001-S
• 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: 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	00868556000222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884623

FDA Product Code

• GIO: TUBE, COLLECTION, CAPILLARY BLOOD

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
• 00868556000215 - HemaTechnologies ESR Control: 2024-06-12
• 00868556000222 - E-Z Safe Tubes: 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