PREIRUS

GUDID 04961333243129

HV-PREIRUS DEMO ESCORT CASE

PENTAX OF AMERICA, INC.

Medical capital equipment storage bag/case

• Primary Device ID: 04961333243129
• NIH Device Record Key: 7e444e54-9e4a-49f4-805a-b4baa5b5ea14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREIRUS
• Version Model Number: HV-PREIRUS 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	04961333243129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093466

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2018-03-12

On-Brand Devices [PREIRUS]

• 04961333243143: ULTRASOUND SYSTEM WITH SONO - DEMO
• 04961333243136: HV-PREIRUS SYSTEM WITHOUT ELASTOGTAPHY
• 04961333243129: HV-PREIRUS DEMO ESCORT CASE
• 04961333243112: ADVANCED DIGITAL ULTRASOUND SYSTEM
• 04961333243105: HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
• 04961333240357: ADVANCED DIGITAL ULTRASOUND SYSTEM (USED)