X-ray Flat Panel Detector

GUDID 06970597830479

CareRay Digital Medical Technology Co., Ltd.

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• Primary Device ID: 06970597830479
• NIH Device Record Key: e175289a-077c-426d-9b97-454949003ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray Flat Panel Detector
• Version Model Number: CareView 3600RF
• Company DUNS: 421333508
• Company Name: CareRay Digital Medical Technology Co., Ltd.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970597830479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202995

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: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [X-ray Flat Panel Detector]

• 06970597830363: CareView 750Cw
• 06970597830349: CareView 750C
• 06970597830257: CareView 1800Cw
• 06970597830240: CareView 1800L
• 06970597830219: CareView 1800R
• 06970597830097: CareView 1500Cw
• 06970597830073: CareView 1500L
• 06970597830066: CareView 1500C
• 06970597830035: CareView 1500P
• 06970597830721: CareView 1800Le
• 06970597830745: CareView 1800Cwe
• 06970597830479: CareView 3600RF
• 06970597830271: CareView 1800RF
• 06970597830752: EverestView 4343X
• 06970597832022: YosemiteView 4343W
• 06970597831049: YosemiteView 3643W