Mediblu MDB01005

GUDID B632MDB01005

MEDIBLU MEDICAL LLC

Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Transportable physiologic monitoring system Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: B632MDB01005
• NIH Device Record Key: 0a821e73-6a53-4edd-869b-6a0a5921891f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediblu
• Version Model Number: MM3
• Catalog Number: MDB01005
• Company DUNS: 117518078
• Company Name: MEDIBLU MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B632MDB01005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120144

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: 2020-07-03
• Device Publish Date: 2020-06-25

On-Brand Devices [Mediblu]

• B632MDB01035: Blu15+
• B632MDB01034: BLU 12+
• B632MDB01028: BLU 12
• B632MDB01027: S12W
• B632MDB01026: S12
• B632MDB01024: HP50P
• B632MDB01023: HA3P
• B632MDB01013: DVC 200
• B632MDB01012: ME12P
• B632MDB01011: ME6P
• B632MDB01010: ME3
• B632MDB01009: FD1
• B632MDB01008: FM02
• B632MDB01007: FM10
• B632MDB01006: MO1
• B632MDB01005: MM3
• B632MDB01004: MM5
• B632MDB01003: MM12
• B632MDB01002: MM15
• B632MDB01001: MM17
• B632MDB01037: MM1
• B632MDB01036: DVC 300
• B632MDB01038: DVC 300 HD
• B632MDB01040: ME15P
• B632MDB01042: HA12P