HOMEDICS

GUDID 10031262101560

Premium Arm Blood Pressure Monitor

FKA DISTRIBUTING CO., LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10031262101560
• NIH Device Record Key: 6625151a-cafb-43cb-961f-20aa43d35200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOMEDICS
• Version Model Number: BPA-960BT
• Company DUNS: 183280973
• Company Name: FKA DISTRIBUTING CO., 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: false
• 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: true

Customer Support Contacts

• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00031262101563 [Primary]
GS1	10031262101560 [Package]; Contains: 00031262101563; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200521

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: 2021-05-10
• Device Publish Date: 2021-05-01

On-Brand Devices [HOMEDICS]

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• 10031262100020: Pulse Oximeter
• 00031262099952: Pulse Oximeter
• 00031262098993: NO TOUCH Infrared Thermometer
• 10031262100204: Hot&Cold Gel Eye Mask
• 10031262099652: Percussion Massager
• 10031262098976: Double-Barrel Body Massager
• 00031262098092: Shiatsu Neck Massager
• 00031262097439: Weighted Massage Wrap
• 10031262095197: Cordless percussion body massager
• 10031262094794: CORDLESS BODY WRAP WITH VIBRATION & HEAT
• 00031262093974: Vibration Neck Massager
• 10031262093520: VIBRATION NECK MASSAGER
• 10031262093513: Shiatsu & Vibration Neck Massager
• 10031262092769: VIBRATION FOOT MASSAGER
• 10031262089196: SHIATSU+VIBRATION BODY MASSAGER WITH SOOTHING HEAT
• 10031262089172: Cordless percussion body massager
• 10031262066623: Shiatsu Neck Massager
• 00031262098986: Non-contact Infrared Body Thermometer
• 10031262101232: Non-contact Infrared Body Thermometer
• 00031262101587: Premium Wrist Blood Pressure Monitor
• 10031262101577: Automatic Arm Blood Pressure Monitor
• 10031262101560: Premium Arm Blood Pressure Monitor
• 00031262101549: WEIGHTED GEL WRAP WITH HEAT
• 00031262101532: WEIGHTED GEL HEATING PAD WITH HEAT
• 00031262101525: WEIGHTED GEL HEATING PAD - 12" X 15"
• 00031262101518: 12" X 24" HEATING PAD WITH GEL
• 00031262101501: 12" X 15" WEIGHTED HEATING PAD
• 00031262101495: 12" x 24" HEATING PAD
• 00031262101488: 12" X 24" HEATING PAD
• 00031262101471: 12" X 15" HEATING PAD
• 00031262101464: 12" X 15" HEATING PAD
• 00031262101457: 12" X 24" HEATING PAD
• 00031262101440: 12" X 15" HEATING PAD
• 00031262101433: CONTOURING BACK SUPPORT WITH HEAT
• 00031262101747: ADJUSTABLE BELT WITH INTEGRATED GEL
• 00031262101723: MULTIUSE HEATING PAD
• 00031262101716: OVERSIZED HEATING PAD
• 00031262101709: OVERSIZED HEATING PAD
• 00031262104168: LUMBAR LIFT BACK STRETCHER
• 00031262101754: WEIGHTED GEL NECK & SHOULDER WRAP
• 10031262102543: "TOTAL RECLINE MASSAGE CUSHION"
• 00031262101808: XL NECK & SHOULDER WRAP
• 00031262101792: XL NECK & SHOULDER WRAP WITH HEAT
• 00031262101785: NECK & SHOULDER WRAP WITH INSTAHEAT
• 00031262101778: NECK & SHOULDER WRAP WITH INSTAHEAT
• 00031262101761: NECK & SHOULDER WRAP WITH INSTAHEAT
• 00031262102263: WEIGHTED MASSAGING HEATING PAD
• 10031262105032: PREMIUM WRIST BLOOD PRESSURE MONITOR
• 10031262105025: PREMIUM ARM BLOOD PRESSURE MONITOR