CARESTREAM DRX-1 System 8622797

GUDID 60889978622795

CARESTREAM DRX-1 SYSTEM

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 60889978622795
• NIH Device Record Key: 449e7a38-5588-4ed2-9ce0-fe231fe20e29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESTREAM DRX-1 System
• Version Model Number: CARESTREAM DRX-1 System
• Catalog Number: 8622797
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, 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	60889978622795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090318

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

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: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [CARESTREAM DRX-1 System]

• 60889971039187: QRAD DRX REFRESHED CONSOLE W/WP
• 60889971035158: DRX-1 SYS CONSOLE ONLY W/DRX-1 SYS SW
• 60889971021229: CARESTREAM DRX-1 SYSTEM
• 60889971003812: DRX-1C MOBILE CONSOLE
• 60889971003690: DRX-1C MOBILE CONSOLE
• 60889978622795: CARESTREAM DRX-1 SYSTEM
• 60889978625925: DRX-1 SYSTEM CONSOLE UPGRADE