EVERDIXIE

GUDID 06971329980080

CAREMATE MEDICAL DEVICE CO., LTD

Aneroid manual sphygmomanometer

• Primary Device ID: 06971329980080
• NIH Device Record Key: d65d79cc-492c-4275-ae42-7ea41866fae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVERDIXIE
• Version Model Number: 143401PUR
• 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	06971329980080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090014

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-01

On-Brand Devices [EVERDIXIE]

• 06971329980233: ZHE920
• 06971329980226: ZHE920BK
• 06971329980219: 143425
• 06971329980202: 143401BK
• 06971329980196: 143407
• 06971329980189: 143406
• 06971329980172: 422208B
• 06971329980165: 645011
• 06971329980158: 645010
• 06971329980141: 422208NO
• 06971329980134: 422208G
• 06971329980110: 422208R
• 06971329980103: 422208RB
• 06971329980097: 422208BUR
• 06971329980080: 143401PUR
• 06971329980073: 422208TL
• 06971329980066: 143412
• 06971329980059: 143401PK
• 06971329980042: 143401
• 06971329980035: 422208PUR
• 06971329980028: 422208PK
• 06971329980011: 422208