BIGTIDE

GUDID 06970438060003

Shenyang Torch-Bigtide Digital Technology Co., Ltd.

Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour

• Primary Device ID: 06970438060003
• NIH Device Record Key: 126f87d5-efc0-4b8d-85b5-f32b845c58ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIGTIDE
• Version Model Number: HL5501S
• Company DUNS: 544970601
• Company Name: Shenyang Torch-Bigtide Digital 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: true
• 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	06970438060003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172969

FDA Product Code

• DXJ: Display, Cathode-Ray Tube, Medical

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: 2022-09-13
• Device Publish Date: 2022-09-05

On-Brand Devices [BIGTIDE]

• 06970438060065: HL5501SP
• 06970438060003: HL5501S