Vive Precision

GUDID 10818323023548

Dual Thermometer New

VIVE HEALTH LLC

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 10818323023548
• NIH Device Record Key: a4d1a603-07bd-4ebd-84f2-464b0d95d706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Precision
• Version Model Number: DMD1035WHT
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• 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	00818323023541 [Primary]
GS1	10818323023548 [Package]; Contains: 00818323023541; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171578

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: 2018-09-03
• Device Publish Date: 2018-08-02

On-Brand Devices [Vive Precision]

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• 10818323024644: Blood Pressure Monitor Replacement Cuffs Small
• 10818323024637: Blood Pressure Monitor Replacement Cuffs Medium
• 10818323024613: Blood Pressure Monitor Replacement Cuffs Large
• 10818323024545: Compact Blood Pressure Monitor (Black)
• 10818323023548: Dual Thermometer New
• 10818323022138: Oral Thermometer Rebrand
• 10818323022091: Pulse Oximeter Bluetooth
• 10818323021841: Wrist BPM
• 10818323020929: Dual Thermometer
• 10818323020271: Sphygmomanometer
• 10818323026631: BPM Silver V2
• 10818323026624: BPM Black V2
• 10810041987584: Blood Pressure Monitor Model: BT-S
• 10810041987546: Wrist Blood Pressure Monitor Model: BT-V
• 10810041987874: Blood Pressure Monitor Model A
• 10810041982404: Digital Thermometer (White)
• 10810113572458: Easy-Twist Lancets (300PK)
• 10818323028864: Smart Body Fat Scale