Gochek2 1017+-PMTL-007

GUDID 06958590302520

Blood Glucose Meter

Microtech Medical (Hangzhou) Co., Ltd.

Glucose analyser IVD, home-use

• Primary Device ID: 06958590302520
• NIH Device Record Key: 1e0218f3-9216-440b-bf57-beaa04174d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gochek2
• Version Model Number: 1017+
• Catalog Number: 1017+-PMTL-007
• Company DUNS: 542987562
• Company Name: Microtech Medical (Hangzhou) 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	06958590302520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193340

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: 2021-11-22
• Device Publish Date: 2021-11-12

On-Brand Devices [Gochek2]

• 06958590303046: Blood Glucose Test strips
• 06958590302520: Blood Glucose Meter
• 06958590303329: Blood Glucose Monitoring System (BG meter and 100pc test strip)
• 06958590308867: Blood Glucose Test Strip, 100pc, double vial
• 06958590308850: Blood Glucose Test Strip, 50pc, double vials