Vive Precision

GUDID 10818323022091

Pulse Oximeter Bluetooth

VIVE HEALTH LLC

Pulse oximeter, battery-powered

• Primary Device ID: 10818323022091
• NIH Device Record Key: 002d7e11-50fc-4263-a81b-8d6ea77abffb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Precision
• Version Model Number: DMD1034WHT
• 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	00818323022094 [Primary]
GS1	10818323022091 [Package]; Contains: 00818323022094; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170965

FDA Product Code

• DQA: Oximeter

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: 2018-02-01

On-Brand Devices [Vive Precision]

• 10818323024859: Bluetooth Blood Pressure Monitor Black
• 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
• 10810113576791: Pulse Oximeter (Model S) (White)
• 10810113577569: Blood Pressure Monitor (Smart Phone Compatible)
• 10810041986761: Blood Pressure Monitor Model: BT-S
• 10810113578832: Infrared Thermometer
• 10810113578702: Easy-Twist Lancets (100PK)
• 10810113577163: ECG Monitor