FLTR

GUDID 10840061480116

Model: PC801; Brand: FLTR; One inner packing box contains 4 device; One outer packing box contains 5 inner packing boxes. Per outer packing box can pack 20 devices.

Shenzhen Pacom Medical Instruments Co., Ltd.

Infrared patient thermometer, ear/skin

• Primary Device ID: 10840061480116
• NIH Device Record Key: 01ad18c9-5f12-43b4-9da5-28a85c78bdd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLTR
• Version Model Number: PC801
• 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	00840061480119 [Primary]
GS1	10840061480116 [Package]; Contains: 00840061480119; Package: Inner packing box [4 Units]; In Commercial Distribution
GS1	20840061480113 [Package]; Package: Outer packing box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190717

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: 2020-10-05
• Device Publish Date: 2020-09-26

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