GROTIN

GUDID 06973127140031

WHITE

Visiomed Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 06973127140031
• NIH Device Record Key: 279ce917-898a-4846-bdce-e3d097b0bd74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GROTIN
• Version Model Number: LX-26E
• Company DUNS: 548235347
• Company Name: Visiomed 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973127140031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160816

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-08-13
• Device Publish Date: 2020-08-05

Devices Manufactured by Visiomed Technology Co., Ltd.

• 06973127140031 - GROTIN: 2020-08-13WHITE
• 06973127140031 - GROTIN: 2020-08-13 WHITE
• 06973127140024 - MIDE: 2020-04-23