CKeep

GUDID 00739810204208

Shenzhen Lingku Ecommerce Co., Ltd.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 00739810204208
• NIH Device Record Key: b5e866db-40f8-4834-83bb-3b7998abe962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CKeep
• Version Model Number: PG-800A12
• 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	00739810204208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131569

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-01

On-Brand Devices [CKeep]

• 00739810210650: PG-800B23
• 00739810204208: PG-800A12
• 00739810204123: JPD-500E
• 00739810203850: JPD-FR408
• 00782905402256: BT-A13
• 00739810205113: BT-A11CN