Shopko 72-332

GUDID 10400119854391

ShopkoTemple Touch Premium Thermomete

VERIDIAN HEALTHCARE LLC

Infrared patient thermometer, skin

• Primary Device ID: 10400119854391
• NIH Device Record Key: b0532a3e-8173-497a-aac9-a0135d3d3e14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shopko
• Version Model Number: 72-332
• Catalog Number: 72-332
• Company DUNS: 830437997
• Company Name: VERIDIAN HEALTHCARE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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

Customer Support Contacts

• Phone: 866-326-1313
• Email: info@veridianhealthcare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00400119854394 [Primary]
GS1	10400119854391 [Package]; Contains: 30400119854395; Package: Master Carton [36 Units]; In Commercial Distribution
GS1	30400119854395 [Package]; Contains: 00400119854394; Package: Intermediate [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051422

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

On-Brand Devices [Shopko]

• 10400190272008: Shopko Ear Thermometer
• 00400168281394: Shopko 12" x 15" Deluxe Heating Pad
• 10400119854704: Shopko Temple Touch Mini Thermometer
• 10400119854391: ShopkoTemple Touch Premium Thermomete
• 00400104418228: Shopko Ear Thermometer