Balance

GUDID 10875011006047

Greater Goods

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10875011006047
• NIH Device Record Key: 4c839efe-65b8-4976-bbe4-11b27f494c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balance
• Version Model Number: 0604
• Company DUNS: 189583599
• Company Name: Greater Goods
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875011006040 [Primary]
GS1	10875011006047 [Package]; Contains: 00875011006040; Package: Master Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131395

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-06-06

On-Brand Devices [Balance]

• 10875011006283: 0628
• 10875011006276: 0627
• 10875011006269: 0626
• 10875011006252: 0625
• 10875011006092: 0609
• 10875011006085: Sphygmomanometer
• 10875011006078: 0607
• 10875011006061: 0606
• 10875011006054: Wrist Blood Pressure Monitor
• 10875011006047: 0604
• 10875011006023: 0602
• 10875011006009: Upper Arm Blood Pressure Monitor
• 10875011003992: 0399
• 10875011003930: Body Composition Scale
• 10875011003916: Body Composition Scale
• 00875011003865: 0386