CKeep

GUDID 00782905402256

Shenzhen Lingku Ecommerce Co., Ltd.

Intermittent electronic patient thermometer

• Primary Device ID: 00782905402256
• NIH Device Record Key: c9f07e75-ed63-4dba-ad9e-b7724bd9bde4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CKeep
• Version Model Number: BT-A13
• 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	00782905402256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101387

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-03-30
• Device Publish Date: 2020-03-20

On-Brand Devices [CKeep]

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