NOBLUS

GUDID 04961333244140

NOBLUS DEMO CRATE

PENTAX OF AMERICA, INC.

Medical capital equipment storage bag/case

• Primary Device ID: 04961333244140
• NIH Device Record Key: ead87981-2869-4ea7-b158-bedd69593c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOBLUS
• Version Model Number: NOBLUS CRATE
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333244140 [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: New
• Device Record Status: Published
• Public Version Number: 2
• 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