Metene

GUDID 00739810210704

Shenzhen Lingku Ecommerce Co., Ltd.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 00739810210704
• NIH Device Record Key: a6da8037-b6db-4513-87ac-e5f81627924c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metene
• Version Model Number: PG-800B9
• Company DUNS: 544434375
• Company Name: Shenzhen Lingku Ecommerce 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: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00739810210704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131558

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2018-10-01
• Device Publish Date: 2018-08-30

On-Brand Devices [Metene]

• 00739810210704: PG-800B9
• 00739810210698: PG-800B8
• 00739810204697: FDIR-V16
• 00739810204109: JPD-500E
• 00739810204055: FDIR-V5
• 00739810204048: FDIR-V16
• 00739810203911: JPD-FR401
• 00739810202990: JPD-FR200
• 00739810210070: FDIR-V9