| Primary Device ID | 40872237009112 |
| NIH Device Record Key | 0a42016a-5db5-4bd6-b27d-f5c0b5e36af6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLOBAL HEALTHCARE |
| Version Model Number | 07-21M |
| Company DUNS | 884718776 |
| Company Name | GHC HEALTHCARE, INC. |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00872237009114 [Primary] |
| GS1 | 40872237009112 [Package] Contains: 00872237009114 Package: CASE [28 Units] In Commercial Distribution |
| FYA | Gown, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-12 |
| Device Publish Date | 2020-08-04 |
| 40872237009181 | XXL Sterile Surgical Gown Level 3 |
| 40872237009174 | XL Sterile Surgical Gown, Blue Level 3 |
| 40872237009167 | Large Sterile Surgical Gown, Blue Level 3 |
| 40872237009112 | Medium Sterile Surgical Gown, Blue Level 3 |
| 40872237001802 | UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000 CC, SYRINGE 10 CC PRE-FILLED WITH ST |