PARAMED

GUDID 00856324008693

Is a digital device used to measure blood pressure (Upper-arm)

SILEX GLOBAL LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00856324008693
• NIH Device Record Key: c830183b-a486-4a1e-9e0d-390b687cae30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARAMED
• Version Model Number: Digital Blood Pressure Monitor (Upper-arm) B22
• Company DUNS: 081135914
• Company Name: SILEX GLOBAL 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: 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	00856324008693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200437

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: 2021-09-16
• Device Publish Date: 2021-09-08

On-Brand Devices [PARAMED]

• 00856324008150: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008136: A medical thermometer is used for measuring human or animal body temperature.
• 00856324008105: Is a device used to measure blood pressure (Wrist)
• 00856324008099: Is a digital device used to measure blood pressure Upper-arm)
• 00856324008082: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008075: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008044: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008037: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008020: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008013: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and th
• 00856324008372: Blood Pressure Cuff Manual. Basic Blue. RENHUA
• 00856324008365: Blood Pressure Cuff Manual. Basic Black. RENHUA
• 00856324008358: Blood Pressure Cuff Manual. Basic Pink. RENHUA
• 00856324008341: Blood Pressure Cuff Manual. Comfort Pink. RENHUA
• 00856324008334: Blood Pressure Cuff Manual. Comfort Blue. RENHUA
• 00856324008327: Blood Pressure Cuff Manual. Comfort Black. RENHUA
• 00856324008426: B51
• 00856324008310: PG-800A11
• 00856324008280: Blood Pressure Cuff Manual. Comfort Black
• 00856324008273: Blood Pressure Cuff Manual. Comfort Blue
• 00856324008266: Blood Pressure Cuff Manual. Comfort Pink
• 00856324008259: Blood Pressure Cuff Manual. Basic Pink
• 00856324008174: Blood Pressure Cuff Manual. Basic Blue
• 00856324008167: Blood Pressure Cuff Manual. Basic Black
• 00856324008488: This device used to measure blood pressure (Wrist)
• 00856324008297: This device used to measure human temparature
• 00856324008181: Is a device used to measure human temparature
• 00856324008693: Is a digital device used to measure blood pressure (Upper-arm)
• 00856324008730: Is a digital device used to measure blood pressure (Upper-arm)
• 00856324008723: Is a digital device used to measure blood pressure (Upper-arm)