CVS Health

GUDID 20050428520066

ELECTRODES for Mini TENS device

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Transcutaneous electrical stimulation electrode

• Primary Device ID: 20050428520066
• NIH Device Record Key: bc33b354-f1d6-4dd8-8624-c15540b583ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVS Health
• Version Model Number: 456207
• Company DUNS: 062312574
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00050428520062 [Primary]
GS1	10050428520069 [Package]; Contains: 00050428520062; Package: Inner Pack [6 Units]; In Commercial Distribution
GS1	20050428520066 [Package]; Contains: 10050428520069; Package: Case Pack [4 Units]; In Commercial Distribution
GS1	30050428520063 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082065

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [CVS Health]

• 00634188000967: Safe containment with optional return & disposal (additional fees may apply). System Includes: n
• 40050428606610: A hand-held battery-powered, electronic instrument designed for oral, vaginal or rectal use to m
• 10050428557188: Body Analysis Scale
• 10050428542634: Ready to Use Wart Freezer Cryogenic Treatment
• 10050428542559: Multi pack of 18 - 9 Regular/9 Super
• 50050428539519: CVS WARMING JELLY 2.5 OZ - (CVS-097-2.5OZ)
• 50050428539458: CVS LUBRICATING LIQUID 2.5 OZ - (CVS-091-2.5OZ)
• 20050428535022: ADHESIVE ELECTRODES
• 00050428534496: CVS PRO DG TENS DEV
• 20050428520066: ELECTRODES for Mini TENS device
• 20050428514454: Mini TENS device
• 00050428454602: CVS153109
• 00504284462702: CVS PERSONAL LUBRICATING GEL 4 OZ - (CVS-024-4OZAST)
• 60050428443943: HEATINGPAD,CVS,BACK,GEL PACK
• 00050428438169: BP3MV1-3XCVS
• 10050428437589: Fingertip Pulse Oximeter
• 10050428434809: BCVPR36
• 10050428427542: BCVUR18
• 10050428426972: Multi pack of 80 - 16 light/32 Regular/32 Super
• 10050428425951: Ready to Use Wart Freezer Cryogenic Treatment
• 60050428424805: Heating Pad
• 60050428423440: HEATINGPAD,CVS,PL,NONVINYL
• 00050428419960: Electronic Pulse Stimulator
• 10050428419004: Fingertip Pulse Oximeter
• 00050428417850: Safe containment with optional return & disposal (additional fees may apply). System Includes: n
• 00050428414590: Body Analysis Scale
• 20050428411104: ADHESIVE ELECTRODES
• 10050428407315: BCVAR54
• 00050428402023: Fingertip Pulse Oximeter
• 00050428400869: 274089
• 10050428400781: Multi pack of 18 - 9 Regular/9 Super
• 10050428398545: Ready to Use Wart Freezer Cryogenic Treatment
• 10050428393335: Multi pack of 54 - 10 light/22 Regular/22 Super
• 10050428389901: Talking Pulse Oximeter
• 60050428385106: Heating Pad
• 00050428381250: Self-adhesive Replacement Gel Pads
• 60050428378412: Heating Pad
• 60050428376357: Heating Pad
• 60050428375190: HEATINGPAD,CVS,WRAP,HT&CLD,GEL
• 10050428371050: Ready to Use Wart Freezer Cryogenic Treatment
• 00050428366769: Cryo Wart Remover
• 40050428360963: A hand-held battery-powered electronic instrument designed to measure a patient's body temperatu
• 60050428360554: Heating Pad
• 10050428355852: Multi pack of 36 - 18 Regular/18 Super
• 10050428345075: BCVXS18
• 60050428337426: HEATINGPAD,CVS,VINYL,STD,3HS
• 60050428336603: HEATINGPAD,CVS,VINYL,KING,3HS
• 10050428333898: Cryo Wart Remover
• 60050428321692: Heating Pad
• 60050428317664: HEATINGPAD,CVS,PL,NONVINYL,KNG