ketodoc Blood Glucose Plus B-Ketone Monitoring System

GUDID 00703674534436

Lancing device*1 Lancet*20pcs Blood glucose test strip*10pcs Ketone test strip*10pcs

Rediston Limited

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 00703674534436
• NIH Device Record Key: 178ea783-053f-40d6-a1ca-d8057bac524a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ketodoc Blood Glucose Plus B-Ketone Monitoring System
• Version Model Number: TD-4141
• Company DUNS: 663519773
• Company Name: Rediston Limited
• 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	00703674534436 [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: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by Rediston Limited

• 00703674534436 - ketodoc Blood Glucose Plus B-Ketone Monitoring System: 2023-03-27Lancing device*1 Lancet*20pcs Blood glucose test strip*10pcs Ketone test strip*10pcs
• 00703674534436 - ketodoc Blood Glucose Plus B-Ketone Monitoring System: 2023-03-27 Lancing device*1 Lancet*20pcs Blood glucose test strip*10pcs Ketone test strip*10pcs
• 00703674534498 - ketodoc B-Ketone Test Strips (40PCS/BOX): 2023-03-27
• 00703674534504 - ketodoc Blood Glucose Test Strips (40PCS/BOX): 2023-03-27