ESR Control Cube 10435

GUDID 08033891328207

DIESSE DIAGNOSTICA SENESE SPA

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: 08033891328207
• NIH Device Record Key: 0b053f50-6133-4811-98b8-aa373148f541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESR Control Cube
• Version Model Number: 10435
• Catalog Number: 10435
• Company DUNS: 435036669
• Company Name: DIESSE DIAGNOSTICA SENESE SPA
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	08033891328207 [Primary]

FDA Product Code

• JPH: Test, Erythrocyte 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: 2022-12-05
• Device Publish Date: 2022-11-25

On-Brand Devices [ESR Control Cube]

• 08033891328757: 10436
• 08033891328207: 10435