| Primary Device ID | 10801741183628 |
| NIH Device Record Key | 65561699-ca97-4df5-be15-adf01f4954ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureStep Male External Catheter System |
| Version Model Number | MECSB010 |
| Catalog Number | MECSB010 |
| Company DUNS | 016898496 |
| Company Name | C. R. Bard, Inc. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741183621 [Primary] |
| GS1 | 10801741183628 [Package] Contains: 00801741183621 Package: CA [1 Units] In Commercial Distribution |
| NNX | DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE |
| PPC | Male external catheterization kit (excludes HIV testing) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-30 |
| Device Publish Date | 2020-09-22 |
| 10801741183635 | SureStep Male External Catheter System - Starter Kit with 350ml Urine Meter and 2500ml Urine Col |
| 10801741183628 | SureStep Male External Catheter System Starter Kit with 2000ml Urine Collection Bag |