ASA Techmed

GUDID 26970366970034

CARDICARE COMPANY LTD

Aneroid manual sphygmomanometer

• Primary Device ID: 26970366970034
• NIH Device Record Key: e36a3254-6ce2-4ffa-b43f-1610e0e733b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASA Techmed
• Version Model Number: AS-MC-PED
• Company DUNS: 528101293
• Company Name: CARDICARE COMPANY 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970366970030 [Primary]
GS1	26970366970034 [Package]; Contains: 06970366970030; Package: MASTER CARTON [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082542

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: 2019-01-04
• Device Publish Date: 2018-12-04

On-Brand Devices [ASA Techmed]

• 26970366970058: AS-MC-TH
• 26970366970041: AS-MC-OB
• 26970366970034: AS-MC-PED
• 26970366970010: Aneroid Sphygmomanometer