| Primary Device ID | 20369771001017 |
| NIH Device Record Key | 08069b9c-54d8-4263-ba5b-7f7d4cc4587a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foley Catheter |
| Version Model Number | 21-020 |
| Company DUNS | 361663839 |
| Company Name | GERI-GENTLE CORPORATION |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00369771001013 [Primary] |
| GS1 | 20369771001017 [Package] Contains: 00369771001013 Package: Inner [10 Units] In Commercial Distribution |
| EZL | Catheter, Retention Type, Balloon |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-12 |
| Device Publish Date | 2019-02-26 |
| 10369771001133 | Foley Catheter 16fr 30cc |
| 20369771001123 | Foley Catheter 24fr 5cc |
| 10369771001119 | Foley Catheter 24fr 30cc |
| 20369771001093 | Foley Catheter 22fr 5cc |
| 10369771001089 | Foley Catheter 22fr 30cc |
| 10369771001072 | Foley Catheter 20fr 5cc |
| 10369771001065 | Foley Catheter 20fr 30cc |
| 10369771001058 | Foley Catheter 18fr 30cc |
| 20369771001048 | Foley Catheter 18fr 5cc |
| 20369771001031 | Foley Catheter 16fr 5cc |
| 20369771001017 | Foley Catheter 14fr 5cc |
| 10369771001003 | Foley Catheter 14fr 30cc |