RENPHO BLOOD PRESSURE MONITOR

GUDID 00860002249681

JOICOM CORPORATION

Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor Transcutaneous central venous pressure sensor

• Primary Device ID: 00860002249681
• NIH Device Record Key: a88d8592-043f-4e81-a253-88c7d855499f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENPHO BLOOD PRESSURE MONITOR
• Version Model Number: RP-BPM004
• 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	00860002249681 [Primary]
GS1	10860002249688 [Package]; Package: [50 Units]; In Commercial Distribution

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: 2020-08-07
• Device Publish Date: 2020-07-30

On-Brand Devices [RENPHO BLOOD PRESSURE MONITOR]

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