Vive Precision

GUDID 10810113578702

Easy-Twist Lancets (100PK)

VIVE HEALTH LLC

Manual blood lancing device, single-use

• Primary Device ID: 10810113578702
• NIH Device Record Key: b06f22af-d6c4-45b2-922f-a76801bf70c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Precision
• Version Model Number: DMD1083BLU100
• 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: true
• 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	00810113578705 [Primary]
GS1	10810113578702 [Package]; Contains: 00810113578705; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222034

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

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

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

[10810113578702]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

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