Mediblu MDB01008

GUDID B632MDB01008

MEDIBLU MEDICAL LLC

Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Cardiotocograph Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor

• Primary Device ID: B632MDB01008
• NIH Device Record Key: 168b27f8-a1db-42fa-aff4-ed33f21e8ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediblu
• Version Model Number: FM02
• Catalog Number: MDB01008
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B632MDB01008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102140

FDA Product Code

• HGM: System, monitoring, perinatal

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