Keto-mojo β-ketone test strips (10pcs/box)

GUDID 00858538007202

KETO-CHECK, INC.

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: 00858538007202
• NIH Device Record Key: b89fa463-cc89-4366-8741-c82fcef837e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Keto-mojo β-ketone test strips (10pcs/box)
• Version Model Number: TD-4279
• Company DUNS: 080577376
• Company Name: KETO-CHECK, INC.
• 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	00858538007202 [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: 2019-03-11
• Device Publish Date: 2019-02-21

Devices Manufactured by KETO-CHECK, INC.

• 00858538007004 - keto mojo β-ketone test strips (50pcs/box): 2019-03-11
• 00858538007103 - keto mojo β-ketone & blood glucose monitoring system: 2019-03-11
• 00858538007202 - Keto-mojo β-ketone test strips (10pcs/box): 2019-03-11
• 00858538007202 - Keto-mojo β-ketone test strips (10pcs/box): 2019-03-11
• 00858538007301 - keto mojo glucose test strips (50pcs/box): 2019-03-11