GUDID 00697077000790

Amico Diagnostic Incorporated

Blood pressure cuff, reusable Blood pressure cuff, reusable

• Primary Device ID: 00697077000790
• NIH Device Record Key: 0a59ed06-cbdb-4ed9-9b11-1d4e103eb4fe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CR2-LF12M-1
• 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	00697077000790 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

Devices Manufactured by Amico Diagnostic Incorporated

• 00697077003029 - NA: 2024-05-10
• 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
• 00697077002961 - NA: 2023-04-26