Bio30+ Physiological HR

GUDID 05056336800277

Ion exchange chromatography analyzer sold with lithium high resolution column and autosampler.

BIOCHROM LIMITED

Amino acid analyser IVD

• Primary Device ID: 05056336800277
• NIH Device Record Key: 12f9716a-6483-45b9-bde8-e02ec09d67de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio30+ Physiological HR
• Version Model Number: 80-6000-57
• Company DUNS: 235280646
• Company Name: BIOCHROM LIMITED
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056336800277 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2023-07-24
• Device Publish Date: 2023-07-14

Devices Manufactured by BIOCHROM LIMITED

• 05056336800192 - Bio30+ System Physio Accel: 2023-07-24 Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software
• 05056336800208 - Bio30+ Physio Accelerated: 2023-07-24 Ion exchange chromatography analyzer sold with lithium accelerated column and autosampler.
• 05056336800215 - Bio30+ Physio Accel W/O A/S: 2023-07-24 Ion exchange chromatography analyzer sold with lithium accelerated column.
• 05056336800222 - Bio30+ System Physio HP: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab s
• 05056336800239 - Bio30+ Sys Physio HP EZ Nin: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab soft
• 05056336800246 - Bio30+ Physio High Performance: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column and autosampler.
• 05056336800253 - Bio30+ Physio W/O A/S HP: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column.
• 05056336800260 - Bio30+ System Physio HR: 2023-07-24 Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab soft