| Primary Device ID | 85006313931100 |
| NIH Device Record Key | 2cd3cc05-8bd7-4baf-b764-d10873df0e03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEIL MEDICAL |
| Version Model Number | Gown |
| Catalog Number | Gown |
| Company DUNS | 122260045 |
| Company Name | Neil Medical Group |
| Device Count | 500 |
| 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 | true |
| Manufacturing Date | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850063139311 [Primary] |
| GS1 | 85006313931100 [Unit of Use] |
| OEA | Non-Surgical Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-14 |
| 00850063139236 | Disposable Nitrile Powder free Examination Gloves |
| 00850063139229 | Disposable Nitrile Powder free Examination Gloves |
| 00850063139212 | Disposable Nitrile Powder free Examination Gloves |
| 00850063139205 | Disposable Nitrile Powder free Examination Gloves |
| 00850063139151 | Stretch Vinyl Powder free Examination gloves |
| 00850063139144 | Stretch Vinyl Powder free Examination gloves |
| 00850063139137 | Stretch Vinyl Powder free Examination gloves |
| 00850063139120 | Stretch Vinyl Powder free Examination gloves |
| 85006313932800 | Personal Tripple Blade Razor |
| 85006313931100 | Isolation Blue Gown |
| 00850063139274 | Pulse Oximeter |
| 00850063139250 | Disposable Face Mask Level 1 |
| 00850063139076 | Vinyl Examination Glove Extra Large |
| 00850063139069 | Vinyl Examination Glove Large |
| 00850063139052 | Vinyl Examination Glove Medium |
| 00850063139007 | Vinyl Examination Glove Small |