AdviewII™ 9005TRK

GUDID 00634782085568

Adview2 Temp Kit,Rectal, Red

AMERICAN DIAGNOSTIC CORP

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 00634782085568
• NIH Device Record Key: 0ca9673b-2cd8-4ed0-9b80-b648be8c895f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdviewII™
• Version Model Number: 9005TRK
• Catalog Number: 9005TRK
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782085568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160439

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [AdviewII™]

• 00634782094911: Adview2 SpO2 Finger Sensor,Reusable, Adult, 8’ cable Canada
• 00634782094898: Adview2 SpO2 Module,ChipOx Canada
• 00634782094461: Adview2 Diagnostic Station,BP only Canada
• 00634782085605: Adview2 Diagnostic Station,BP/SpO2 Masimo Set/Temp Modules
• 00634782085599: Adview2 Diagnostic Station,BP/SpO2Masimo Set Modules
• 00634782085568: Adview2 Temp Kit,Rectal, Red
• 00634782085551: Adview2 Temp Kit,Oral/Axillary, Blue
• 00634782085544: Adview2 Thermometer Module,Rectal, Red
• 00634782085537: Adview2 SpO2 Multisite Sensor,10 Adult, 10 Ped wraps
• 00634782085520: Adview2 SpO2 Module,Masimo Set
• 00634782085513: Adview2 Pediatric Cuff Kit,
• 00634782085506: Adview2 Adult Cuff Kit,
• 00634782085490: Adview2 Five Cuff Kit,
• 00634782085452: Shelf for Adview2 Printer,on Mobile Stand
• 00634782085438: Adview2 USB Cable,6’, USB to mini-USB
• 00634782085421: Adview2 Calibration Plug,for Temp Module
• 00634782085407: Adview2 Cuff, 1 Tube,Child, Green, w/Male Bayonet
• 00634782085391: Adview2 Cuff, 1 Tube,Thigh, Brown, w/Male Bayonet
• 00634782085384: Adview2 Cuff, 1 Tube,LgAdult Plus,Burgundy,wBayonet
• 00634782085377: Adview2 Cuff, 1 Tube,Lg Adult, Burgundy, w/MBayonet
• 00634782085360: Adview2 Cuff, 1 Tube,Adult Plus, Navy, w/M Bayonet
• 00634782085353: Adview2 Cuff, 1 Tube,Adult, Navy, w/Male Bayonet
• 00634782085346: Adview2 Cuff, 1 Tube,SmAdult, RoyBlu, Male Bayonet
• 00634782084820: Adview2 Barcode Scanner,w/Holster
• 00634782084813: Paper for Adview2 Printer,Tray of 10 rolls
• 00634782084806: Adview2 Printer ,w/Paper
• 00634782084790: Adview2 Wi-Fi Dongle,AC Dual Band USB Adapter
• 00634782084783: Adview2 Wall Mount Bracket w/Basket,
• 00634782084776: Adview2 Mobile Stand
• 00634782084769: Adview2 Desktop Storage Caddy
• 00634782084752: Adview2 Thermometer Well,Rectal, Red
• 00634782084745: Adview2 Thermometer Well,Oral/Axillary, Blue
• 00634782084738: Adview2 Thermometer Module,Oral/Axillary, Blue
• 00634782084721: Adview2 SpO2 Finger Sensor,Reusable, Adult, 8’ cable
• 00634782084714: Adview2 SpO2 Module,ChipOx
• 00634782084707: Adview2 BP Cable, 10’,Single Lumen, Bayonet-Bayonet
• 00634782084691: Adview2 Power Cord, USA,120VAC
• 00634782084684: Adview2 Battery, Lithium-ion
• 00634782084677: Adview2 Diagnostic Station,BP/Temp Modules
• 00634782084660: Adview2 Diagnostic Station,BP/SpO2/Temp Modules
• 00634782084653: Adview2 Diagnostic Station,BP/SpO2 Modules
• 00634782084646: Adview2 Diagnostic Station,BP only
• 00634782094942: Adview2 2D Barcode Scanner
• 00634782094935: Adview2 Linear Barcode Scanner