| Primary Device ID | 00860012717613 |
| NIH Device Record Key | 0fe168ad-6f94-4f4c-af15-83226842ab88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlowKeepers Gel Pads |
| Version Model Number | Gel Pad Envelope |
| Company DUNS | 144867619 |
| Company Name | KRENERB |
| 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 | 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 |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com | |
| Phone | 3023885016 |
| info@flowkeepers.com |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Area/Surface Area | 2.3 Square centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012717613 [Primary] |
| GS1 | 10860012717610 [Package] Package: Box [2 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-06 |
| Device Publish Date | 2025-12-29 |
| 00860012717613 - FlowKeepers Gel Pads | 2026-01-06Gel pad envelope with 2 packs of 2 gel pads each, Total of 4 gel packs |
| 00860012717613 - FlowKeepers Gel Pads | 2026-01-06 Gel pad envelope with 2 packs of 2 gel pads each, Total of 4 gel packs |
| 00860012717637 - FlowKeepers | 2025-11-24 FlowKeepers Pro Bundle with two devices and 8 gel pads. |