| Primary Device ID | 10843356101789 |
| NIH Device Record Key | 0d6469e4-d18d-47dd-a8f1-9edde733d67d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa |
| Version Model Number | BNK-T-BBHJ-PAD-M |
| 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 | true |
| 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 | 00843356101782 [Primary] |
| GS1 | 10843356101789 [Package] Contains: 00843356101782 Package: [25 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 | 2022-04-08 |
| Device Publish Date | 2022-03-31 |
| 00843356101812 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 | 2025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All cli |
| 00843356101829 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 | 2025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R version on Gator Clips - All cli |
| 10843356102694 - CYGNUS | 2024-12-19 Tip Gard 500 Per Bag, 2000 Per Case |
| 90843356102744 - CYGNUS | 2024-11-28 Enhanced Coating Single Cycle, EC0308 100 per case |
| 90843356102751 - CYGNUS | 2024-11-28 Enhanced Coating Single Cycle, EC0308 with label 100 per case |
| 90843356102768 - CYGNUS | 2024-11-28 Enhanced Coating Single Cycle, EC0612 100 per case |
| 90843356102775 - CYGNUS | 2024-11-28 Enhanced Coating Single Cycle, EC0612 with label 100 per case |
| 90843356102782 - CYGNUS | 2024-11-28 Enhanced Coating Single Cycle, EC0713 60 per case |