ProStim Electrodes 31705

GUDID 00733657258387

ProStim Electrodes, 2" x 4" Oval

ALIMED, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00733657258387
• NIH Device Record Key: 9d5e0995-7d22-4f5b-997b-7f13cda5a2d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProStim Electrodes
• Version Model Number: 31700
• Catalog Number: 31705
• Company DUNS: 056007248
• Company Name: ALIMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com
• Phone: +1(781)329-2900
• Email: bthomas@alimed.com

Device Dimensions

• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch
• Device Size Text, specify: 0
• Length: 2 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device kept at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733657258387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

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: 2016-09-01

On-Brand Devices [ProStim Electrodes]

• 00733657258394: ProStim Electrodes, 2" x 3-1/2 Rectangle
• 00733657258387: ProStim Electrodes, 2" x 4" Oval
• 00733657258370: ProStim Electrodes, 1-1/2" x 2-1/2 " Oval
• 00733657258363: ProStim Electrodes, 1-1/4" Round
• 00733657258356: ProStim Electrodes, 2-3/4" Round
• 00733657258349: ProStim Electrodes, 2" Round
• 00733657258332: ProStim Electrodes, 2" Square, ca/40