bkt ß-Ketone Test Strips (100 pcs/box)

GUDID 00860005745906

Adam Lawrence

Ketone (acetoacetate) IVD, reagent

• Primary Device ID: 00860005745906
• NIH Device Record Key: a9978160-32d9-429f-9598-1bc88b9fe184
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bkt ß-Ketone Test Strips (100 pcs/box)
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00860005745906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

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: 2020-12-30
• Device Publish Date: 2020-12-22

Devices Manufactured by Adam Lawrence

• 00860005745913 - bkt ß-Ketone Test Strips (50 pcs/box): 2022-10-21
• 00858538007127 - bkt ß-Ketone & blood glucose monitoring system: 2022-09-19 Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS
• 00860005745944 - bkt ß-Ketone & blood glucose monitoring system: 2021-03-23
• 00860005745906 - bkt ß-Ketone Test Strips (100 pcs/box): 2020-12-30
• 00860005745906 - bkt ß-Ketone Test Strips (100 pcs/box): 2020-12-30
• 00860005745920 - bkt Blood Glucose Test Strips (50pcs/box): 2020-12-30