NOBLUS

GUDID 04961333244157

HITACHI NOBLUS UTRASND PROC

PENTAX OF AMERICA, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 04961333244157
• NIH Device Record Key: 4a33cea4-c4da-4264-bb1f-ef3c2a41424a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOBLUS
• Version Model Number: NOBLUS-B
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333244157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142368

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2018-07-06
• Device Publish Date: 2018-03-15

On-Brand Devices [NOBLUS]

• 04961333244157: HITACHI NOBLUS UTRASND PROC
• 04961333244140: NOBLUS DEMO CRATE
• 04961333244133: HITACHI NOBLUS UTRASND PROC W/ SONOELAST