GUDID 00697077002978

Amico Diagnostic Incorporated

Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable

• Primary Device ID: 00697077002978
• NIH Device Record Key: f6215bbe-ab3c-4ccd-9039-76965fb7ef58
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CR2-LFMLT-2BVSF
• Company DUNS: 203163290
• Company Name: Amico Diagnostic Incorporated
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697077002978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012444

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: 2023-07-13
• Device Publish Date: 2023-07-05

Devices Manufactured by Amico Diagnostic Incorporated

• 00697077002237 - NA: 2023-08-04
• 00697077002985 - NA: 2023-08-04
• 00697077002992 - NA: 2023-08-04
• 00697077003005 - NA: 2023-08-04
• 00697077003012 - NA: 2023-08-04
• 00697077002978 - NA: 2023-07-13
• 00697077002978 - NA: 2023-07-13
• 00697077002961 - NA: 2023-04-26
• 00697077002923 - NA: 2022-02-10