| Primary Device ID | 00850056286046 |
| NIH Device Record Key | b8bfd53c-afb8-428b-9f77-62fd51a9e9d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medical Shipment |
| Version Model Number | 12001 |
| Company DUNS | 962616673 |
| Company Name | Medical Shipment, LLC |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056286046 [Primary] |
| GS1 | 00850056286053 [Package] Package: Case [20 Units] In Commercial Distribution |
| KYZ | Syringe, Irrigating (Non Dental) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-05 |
| Device Publish Date | 2023-08-28 |
| 00850056286060 | IV Start Kit w/ CHG, Transparent Dressing & Nitrile Gloves, Sterile, 1/each |
| 00850056286046 | Irrigation Tray w/ 60mL Piston Syringe, 1/each |
| 00850056286022 | 100% Silicone Foley Catheter Kit w/ BZK Swabsticks, 16Fr, 1/each |
| 00850056286008 | 100% Silicone Foley Catheter Kit w/ BZK Swabsticks, 14Fr, 1/each |