Blood Pressure Monitor CH-657

GUDID 00845717004046

CITIZEN SYSTEMS JAPAN CO.,LTD.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 00845717004046
• NIH Device Record Key: 64ac10ac-bc18-468f-a17f-3d803d9f8b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Pressure Monitor CH-657
• Version Model Number: CH657V1
• Company DUNS: 711510540
• Company Name: CITIZEN SYSTEMS JAPAN CO.,LTD.
• 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: true
• Manufacturing Date: false
• 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	00845717004046 [Primary]
GS1	10845717004043 [Package]; Contains: 30845717004047; Package: Carton [4 Units]; In Commercial Distribution
GS1	30845717004047 [Package]; Package: Carton [3 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-24

Devices Manufactured by CITIZEN SYSTEMS JAPAN CO.,LTD.

• 00845717004022 - Blood Pressure Monitor CH-4532: 2019-11-08
• 00845717004046 - Blood Pressure Monitor CH-657: 2019-11-08
• 00845717004046 - Blood Pressure Monitor CH-657: 2019-11-08
• 00845717007160 - Blood Pressure Monitor CHU305: 2019-11-08