Braun

GUDID 00328785004380

Braun Thermoscan 6 SIOC for Amazon

KAZ USA, INC.

Infrared patient thermometer, ear

• Primary Device ID: 00328785004380
• NIH Device Record Key: 60caeb98-e4d3-4d4c-b65f-e14e190e404d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Braun
• Version Model Number: IRT6515AM
• Company DUNS: 122612547
• Company Name: KAZ USA, 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: false
• 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	00328785004380 [Primary]
GS1	10328785004387 [Package]; Package: case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103800

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: 2020-10-07
• Device Publish Date: 2020-09-29

On-Brand Devices [Braun]

• 00328785005981: BRAUN 3 IN 1 NO TOUCH THERMOMETER
• 10328785006169: Braun, Nasal Aspriator
• 00328785004380: Braun Thermoscan 6 SIOC for Amazon
• 10328785006657: BRAUN NO TOUCH 3-IN-1 THERMOMETER
• 10328785004899: BRAUN SWIPE TEMPORAL THERMOMETER
• 10328785008002: BRAUN NASAL ASPIRATOR FILTER 40 PACK
• 10328785004752: THERMOSCAN 4 THERMOMETER WITH FEVER GUIDANCE Preliminary
• 10328785002956: Braun, Nasal Aspirator
• 10328785003922: Touch + No Touch Thermometer
• 00328785002911: UPC/UDI BRAUN HEARING AID SINGLE DEVICE CHAMPAGNE (Contains unit of use 10328785002901)
• 00328785007909: BRAUN THERMOSCAN 7 PLUS CONNECTED
• 00328785006919: BRAUN PULSE OXIMETER
• 00328785009583: BRAUN THERMOSCAN 7 WHITE
• 00328785012392: BRAUN DIGITAL STICK WITH FEVER GUIDANCE