FLTR

GUDID 10840061486828

Model: PC868; Brand: FLTR; One inner packing box contains 4 devices; One outer packing box contains 5 inner packing boxes.

Shenzhen Pacom Medical Instruments Co., Ltd.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 10840061486828
• NIH Device Record Key: 356a5480-6069-44b7-a71e-6603f6fd0762
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLTR
• Version Model Number: PC868
• 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	00840061486821 [Primary]
GS1	10840061486828 [Package]; Contains: 00840061486821; Package: Inner Packing Box [4 Units]; In Commercial Distribution
GS1	20840061486825 [Package]; Package: Outer Packing Box [5 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: 2020-07-27
• Device Publish Date: 2020-07-17

On-Brand Devices [FLTR]

• 10840061486811: Model: PC868; Brand: FLTR; One inner packing box contains 2 devices; One outer packing box conta
• 10840061486828: Model: PC868; Brand: FLTR; One inner packing box contains 4 devices; One outer packing box conta
• 00840061482823: Model: PC828; Brand: FLTR; One inner packing tray contains 6 devices; One outer packing box cont
• 10840061482813: Model: PC828; Brand: FLTR; One inner packing box contains 1 device; One outer packing box contai
• 10840061480116: Model: PC801; Brand: FLTR; One inner packing box contains 4 device; One outer packing box contai