Pip Control Solution Normal

GUDID 08809301162200

PHILOSYS Co., Ltd

Glucose monitoring system IVD, home-use

• Primary Device ID: 08809301162200
• NIH Device Record Key: d4446ec8-2399-45c9-be8b-94142bb173fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pip Control Solution Normal
• Version Model Number: PC002-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	08809301162200 [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
• 08809301162200 - Pip Control Solution Normal: 2020-09-21
• 08809301162200 - Pip Control Solution Normal: 2020-09-21
• 08809301162217 - Pip Control Solution High: 2020-09-21