Caroune

GUDID 08400614000007

Name: Multifunctional Infrared Thermometer Model: PC809 Brand: Caroune Test Sites: Ear, Forehead Battery: 2pcs AAA batteries

Shenzhen Pacom Medical Instruments Co., Ltd.

Infrared patient thermometer, ear/skin

• Primary Device ID: 08400614000007
• NIH Device Record Key: c5bbdb80-71ef-4340-b9fb-24f5fd751cad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caroune
• Version Model Number: PC809
• 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	08400614000007 [Primary]
GS1	18400614000004 [Package]; Package: corrugated container [100 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: 2019-11-08
• Device Publish Date: 2019-10-31

Devices Manufactured by Shenzhen Pacom Medical Instruments Co., Ltd.

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• 10840061482813 - FLTR: 2020-08-25 Model: PC828; Brand: FLTR; One inner packing box contains 1 device; One outer packing box contains 52 inner packing boxes.
• 00840061482823 - FLTR: 2020-08-25 Model: PC828; Brand: FLTR; One inner packing tray contains 6 devices; One outer packing box contains 36 inner packing trays.
• 10840061486828 - FLTR: 2020-07-27 Model: PC868; Brand: FLTR; One inner packing box contains 4 devices; One outer packing box contains 5 inner packing boxes.
• 10840061486811 - FLTR: 2020-06-02 Model: PC868; Brand: FLTR; One inner packing box contains 2 devices; One outer packing box contains 26 inner packing boxes.