RENPHO Blood Pressure Monitor

GUDID 04897106770045

JOICOM CORPORATION

Transcutaneous central venous pressure sensor

• Primary Device ID: 04897106770045
• NIH Device Record Key: af1c2cf4-d8a1-494c-809b-81ec9805c91e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENPHO Blood Pressure Monitor
• Version Model Number: RP-BPM001S
• Company DUNS: 081060692
• Company Name: JOICOM CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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	04897106770045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120058

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

On-Brand Devices [RENPHO Blood Pressure Monitor]

• 10860002249640: RP-BPM003
• 00860002249681: RP-BPM004
• 04897106770045: RP-BPM001S
• 10850023727012: RP-BPM001S
• 10850023727029: RP-BPM001