Famidoc

GUDID 06970389631338

Famidoc Technology 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

• Primary Device ID: 06970389631338
• NIH Device Record Key: 0874684b-958c-4b94-99b7-f2855abdf9f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Famidoc
• Version Model Number: FDIR-V8-3
• Company DUNS: 421343701
• Company Name: Famidoc Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	06970389631338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113761

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: 2023-09-29
• Device Publish Date: 2023-09-21

On-Brand Devices [Famidoc]

• 10818218022120: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218022045: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218022038: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218022014: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218021109: This thermometer is intended with non-contact to measurement forehead temperature at home or hos
• 10818218020027: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218020010: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 06970389634018: The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，P
• 06970389631222: FDIR-V22
• 06970389631161: FDIR-V16
• 06970389631154: FDIR-V15
• 06970389631109: FDIR-V10
• 06970389631093: FDIR-V9
• 06970389631079: FDIR-V7
• 06970389631062: FDIR-V6
• 06970389631055: FDIR-V5
• 06970389631048: FDIR-V4
• 06970389631031: FDIR-V3
• 06970389631024: FDIR-V2
• 06970389631017: FDIR-V1
• 06970389630102: The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，P
• 06970389630096: The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，P
• 00854314007268: FDES107
• 00854314007251: FDIR-V4
• 00854314007176: FDIR-V4
• 00854314007169: FDES116
• 00854314007138: FDIR-V16
• 00854314007060: FDES108
• 00854314007022: FDES108
• 06970389634162: FDES116
• 06970389634087: FDES108
• 06970389631277: FDIR-V16
• 06970389631215: FDIR-V4
• 00818218024783: FDES108
• 00818218024776: FDES107
• 00818218021041: FDIR-V4
• 00818218023014: FDBP-A4
• 06970389632250: FDIR-V22
• 06970389632342: FDIR-V24
• 06970389632328: FDIR-V13
• 06970389632281: FDIR-V12
• 06970389632168: FDTH-V0-16
• 06970389632151: FDTH-V0-15
• 06970389632144: FDTH-V0-14
• 06970389632137: FDTH-V0-13
• 06970389632113: FDTH-V0-11
• 06970389632090: FDTH-V0-9
• 06970389632083: FDTH-V0-8
• 06970389632076: FDTH-V0-7
• 06970389632069: FDTH-V0-6