Infrared Thermometer

GUDID 10840061482806

Model: PC828; Brand: None.

Shenzhen Pacom Medical Instruments Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 10840061482806
• NIH Device Record Key: 815cf375-05ec-4343-8afd-02725e4ec364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrared Thermometer
• Version Model Number: PC828
• Company DUNS: 421356348
• Company Name: Shenzhen Pacom Medical Instruments 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: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840061482809 [Primary]
GS1	10840061482806 [Package]; Contains: 00840061482809; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172889

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Infrared Thermometer]

• 10840061486804: Model: PC868; Brand: None.
• 10840061482806: Model: PC828; Brand: None.
• 00840061480904: Model: PC809; Brand: None.
• 10840061482905: Model: PC829; Brand: None.
• 10840061481601: Model: PC816; Brand: None.