Freedom Stim

GUDID 00677346320835

2" x 3.5" Butterfly w/ Lead

PEPIN MANUFACTURING, 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: 00677346320835
• NIH Device Record Key: 4eb144a5-d0a3-4a20-9f29-aa0823152630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Stim
• Version Model Number: TF900L
• Company DUNS: 807703996
• Company Name: PEPIN MANUFACTURING, INC.
• Device Count: 2
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677346300776 [Unit of Use]
GS1	00677346310775 [Primary]
GS1	00677346320811 [Package]; Contains: 00677346310775; Package: [12 Units]; In Commercial Distribution
GS1	00677346320828 [Package]; Contains: 00677346310775; Package: [50 Units]; In Commercial Distribution
GS1	00677346320835 [Package]; Contains: 00677346310775; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070807

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: 2017-01-19

On-Brand Devices [Freedom Stim]

• 00677346321016: 2" x 3.5" Butterfly w/Snap
• 00677346320927: 2" x 3.5" Butterfly w/ Snap
• 00677346320897: 2" x 3.5" Butterfly w/ Snap
• 00677346320866: 2"x 3.5" Pediatric Butterfly w/ Snap
• 00677346320835: 2" x 3.5" Butterfly w/ Lead
• 00677346320804: 2"x 3.5" Butterfly w/ Snap
• 00677346320774: 2" x 3.5" Pediatric Butterfly w/ Snap
• 00677346320767: 2" x 3.5" Butterfly w/ snap