FOND Non-contact Infrared Thermometer

GUDID 06953775654333

Alicn Medical Shenzhen, Inc.

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Primary Device ID	06953775654333
NIH Device Record Key	cad174d4-a32f-44d2-bf32-0de96979b776
Commercial Distribution Status	In Commercial Distribution
Brand Name	FOND Non-contact Infrared Thermometer
Version Model Number	AET-R161
Company DUNS	548040741
Company Name	Alicn Medical Shenzhen, Inc.
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	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953775654333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180207

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	2019-04-29
Device Publish Date	2019-04-20

On-Brand Devices [FOND Non-contact Infrared Thermometer]

06953775654333	AET-R161
06953775652230	AET-R171
06953775650038	AET-R1D1
06953775650021	AET-R1D2
06953775650014	AET-R1B1