ROLLER 10 PLUS NEEDLE SI R10-PN

GUDID 08056040144497

ALIFAX SRL

Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 08056040144497
• NIH Device Record Key: bfe6b2cd-69a0-4ac5-b8f5-1a0477c91226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROLLER 10 PLUS NEEDLE
• Version Model Number: ROLLER 10 PLUS NEEDLE
• Catalog Number: SI R10-PN
• Company DUNS: 435930630
• Company Name: ALIFAX SRL
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056040144497 [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: 2022-10-14
• Device Publish Date: 2022-10-06

Devices Manufactured by ALIFAX SRL

• 08056040148778 - LIGHT SCATTERING TEST KIT: 2022-10-28
• 08056040148945 - TEST1 2.0: 2022-10-21
• 08056040140024 - LATEX CONTROLS: 2022-10-14
• 08056040140031 - LATEX CONTROLS: 2022-10-14
• 08056040140048 - LATEX CALIBRATORS: 2022-10-14
• 08056040140086 - URO-QUICK SCREENING KIT: 2022-10-14
• 08056040140291 - ALFRED 60: 2022-10-14
• 08056040140307 - HB&L UROQUATTRO: 2022-10-14