Pip Control Solution Low

GUDID 08809301162194

PHILOSYS Co., Ltd

Glucose monitoring system IVD, home-use

• Primary Device ID: 08809301162194
• NIH Device Record Key: f43af2e6-12c2-42b4-93d6-987848e02159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pip Control Solution Low
• Version Model Number: PC001-US
• Company DUNS: 690184887
• Company Name: PHILOSYS Co., Ltd
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809301162194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151658

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-09-21
• Device Publish Date: 2020-09-11

Devices Manufactured by PHILOSYS Co., Ltd

• 08809301160862 - Pip Blood Glucose Monitoring System: 2020-09-21
• 08809301161777 - Pip Blood Glucose Test Strips: 2020-09-21
• 08809301162194 - Pip Control Solution Low: 2020-09-21
• 08809301162194 - Pip Control Solution Low: 2020-09-21
• 08809301162200 - Pip Control Solution Normal: 2020-09-21
• 08809301162217 - Pip Control Solution High: 2020-09-21