Greater Goods

GUDID 10875011000304

0030 Omada BGM- RPM

Greater Goods

Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 10875011000304
• NIH Device Record Key: f21079bc-91fb-4798-a835-242fe1491ad3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Greater Goods
• Version Model Number: 0030
• 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: true
• 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	00875011000307 [Primary]
GS1	10875011000304 [Package]; Contains: 00875011000307; Package: Master carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120351

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-19
• Device Publish Date: 2021-07-11

On-Brand Devices [Greater Goods ]

• 10875011006122: OPP Stethescope
• 10875011006139: Mid-Tier Stethoscope
• 10875011006344: BPM - PRO BPM BT
• 10875011006191: Pink Stethoscope
• 10875011006177: Green Stethoscope
• 00875011006156: White Stethoscope
• 10875011006146: Stethoscope (Black)
• 10875011006030: Bluetooth Wrist BPM
• 10875011000304: 0030 Omada BGM- RPM
• 10875011006207: 0620 - gG Classic Stethoscope - like sku 0609 Update
• 00875011006620: OPP BPM NON-KITTED VERSION OF 0602
• 00875011006323: BPM - PRO BPM
• 10875011006900: Oral Thermometer
• 10875011000038: Bluetooth Pulse Oximeter (RPM)
• 10875011006481: BPM w/ XL soft cuff
• 00875011006910: Oral Thermometer with cover
• 10875011000311: 0031 Cellular BGM