PainAway Pro

GUDID 50822383549410

BackSzLong-Last Elctrde,RTLAGF-900

Drive Devilbiss Healthcare

Transcutaneous electrical stimulation lead

• Primary Device ID: 50822383549410
• NIH Device Record Key: d0078d04-1b7c-4454-b749-c67e23d2f564
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PainAway Pro
• Version Model Number: RTLAGF-920
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383549415 [Primary]
GS1	10822383549412 [Package]; Contains: 00822383549415; Package: [50 Units]; In Commercial Distribution
GS1	50822383549410 [Package]; Contains: 10822383549412; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102598

FDA Product Code

• NUH: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

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: 2019-10-23
• Device Publish Date: 2016-07-01

On-Brand Devices [PainAway Pro]

• 50822383549465: 2" Round Long Lasting Electrodes
• 10822383549436: Recharger Kit,RTLAGF-900
• 50822383549410: BackSzLong-Last Elctrde,RTLAGF-900
• 10822383549405: Receiver for RTLAGF-900
• 10822383543724: PainAway Wireless TENS