paramed

GUDID 00856324008181

Is a device used to measure human temparature

SILEX GLOBAL LLC

Infrared patient thermometer, ear/skin

• Primary Device ID: 00856324008181
• NIH Device Record Key: 438de902-b57c-4660-8978-dfea685f56ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: paramed
• Version Model Number: Infrared ear/forehead thermometer YK-IRT1
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-307-212-8504
• Email: silexglobal@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856324008181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180314

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-06-29
• Device Publish Date: 2020-06-19

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)
• 00856324008440: A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gas
• 00856324008129: Dula head stethoscope
• 00856324008112: Single head stethoscope