AMPMED

GUDID 00810477022791

AMPLIM, LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00810477022791
• NIH Device Record Key: 9143ea5c-b234-47c4-b125-901c4a328574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPMED
• Version Model Number: AMP1910
• Company DUNS: 080521945
• Company Name: AMPLIM, LLC
• 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: true
• Manufacturing Date: true
• 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	00810477022791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2019-11-18
• Device Publish Date: 2019-11-09

On-Brand Devices [AMPMED]

• 00810477022197: AMP1701
• 00810477022180: AMP1701
• 00810477022319: AMP1910
• 08104770219098: AMP1812
• 00810477021909: AMP1812
• 00810477021749: AMP1701
• 00810477021558: AMP1701
• 00810477022791: AMP1910
• 00810477022302: AMP1907
• 00810477022296: AMP1907
• 00810477022852: AMP701
• 00810477022845: AMP2001J1
• 00810477022838: AMP1701
• 00810477022821: AMP2001W2
• 00810477022807: AMP1701W1
• 00810477022784: AMP1812A
• 00810477022876: AMP2001F2
• 00810477022883: AMP-CA3
• 00810477022869: AMP-CA2
• 00810477023637: AMPAE3W
• 00810477023620: AMPW1W
• 00810477023613: AMPCA3W
• 00810477023606: AMPCA1W
• 00810477023118: AMPW3B
• 00810477023101: AMPW3A
• 00810477023668: AMPCA2W
• 00810477023651: AMPF2W
• 00810477023125: AMP1706
• 00810477023170: AMP1708
• 00810477023163: AMP1707