Monosed® ESR Vacuum Tubes, Carton PRD-PRV11V-H12

GUDID 03661540300219

ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

ELITECHGROUP INC.

Evacuated erythrocyte sedimentation rate (ESR) tube IVD

• Primary Device ID: 03661540300219
• NIH Device Record Key: d834df18-8a2b-4755-b353-0e1e598235c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monosed® ESR Vacuum Tubes, Carton
• Version Model Number: PRD-PRV11V-H12
• Catalog Number: PRD-PRV11V-H12
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• Device Count: 16
• 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: 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	03661540300219 [Unit of Use]
GS1	03661540300295 [Primary]

FDA Product Code

• GKB: Device, Automated Sedimentation Rate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-10-01

On-Brand Devices [Monosed® ESR Vacuum Tubes, Carton]

• 03661540300219: ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantit
• 03661540300202: ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantit