| Primary Device ID | 10843356100294 |
| NIH Device Record Key | 94367cdb-3052-4eb2-bbcd-58791280cb9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad |
| Version Model Number | EP-6 |
| Company DUNS | 103169095 |
| Company Name | CYGNUS MEDICAL L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843356100297 [Primary] |
| GS1 | 10843356100294 [Package] Contains: 00843356100297 Package: [10 Units] In Commercial Distribution |
| GS1 | 20843356100291 [Package] Contains: 00843356100297 Package: [30 Units] In Commercial Distribution |
| GS1 | 30843356100298 [Package] Contains: 00843356100297 Package: [15 Units] In Commercial Distribution |
| MNL | Accessories, Cleaning Brushes, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 10843356100294 | First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad - 1 Pouch |
| 10843356100263 | First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad - 1 Pouch |
| 10843356100256 | First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad - 1 Pouch |