LOTFANCY

GUDID 06971329980332

CAREMATE MEDICAL DEVICE CO., LTD

Aneroid manual sphygmomanometer

• Primary Device ID: 06971329980332
• NIH Device Record Key: 5d20c4c4-897f-429e-8cab-5ab68b2de1fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTFANCY
• Version Model Number: CM-BPM for Comber
• Company DUNS: 421090818
• Company Name: CAREMATE MEDICAL DEVICE 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: 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	06971329980332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102792

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [LOTFANCY]

• 06971329980332: CM-BPM for Comber
• 06971329980325: CM-BPM for Adult-2
• 06971329980318: LotFancy 11C-1827-G Blue, single head stethoscope
• 06971329980301: CM-BPM for Thigh
• 06971329980295: CM-BPM for LA
• 06971329980271: CM-BPM for Adult