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

GUDID 00860005745906

Adam Lawrence

Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent 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