| Primary Device ID | 10843356100263 |
| NIH Device Record Key | 64e8e802-9dc2-4f65-a8b4-9e27a7647913 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad |
| Version Model Number | EP-4 |
| 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 | 00843356100266 [Primary] |
| GS1 | 10843356100263 [Package] Contains: 00843356100266 Package: [35 Units] In Commercial Distribution |
| GS1 | 20843356100260 [Package] Contains: 00843356100266 Package: [70 Units] In Commercial Distribution |
| GS1 | 40843356100264 [Package] Contains: 00843356100266 Package: [2100 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 |