bkt ß-Ketone & blood glucose monitoring system

GUDID 00858538007127

Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS

Adam Lawrence

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 00858538007127
• NIH Device Record Key: ffe702a2-6c3d-4ad1-bfdb-7bdcdf7a1a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bkt ß-Ketone & blood glucose monitoring system
• Version Model Number: TD-4279
• Company DUNS: 117734901
• Company Name: Adam Lawrence
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00858538007127 [Primary]

FDA Product Code

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

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: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [bkt ß-Ketone & blood glucose monitoring system]

• 00860005745944: TD-4279
• 00858538007127: Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS