| Primary Device ID | 06971004782879 |
| NIH Device Record Key | 13652388-8acf-4927-a99c-7751f0a31a6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZD Isolation Gown-CP |
| Version Model Number | ZDB120001A |
| Company DUNS | 421272799 |
| Company Name | Xuchang Zhengde Environstar Medical Products Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +86 18257583478 |
| ashine@zhende.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971004782862 [Primary] |
| GS1 | 06971004782879 [Package] Contains: 06971004782862 Package: Case [10 Units] In Commercial Distribution |
| OEA | Non-Surgical Isolation 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 | 2020-04-27 |
| Device Publish Date | 2020-04-17 |
| 06971004782893 | Isolation Gown, XL, 10 pieces/bag, 10 bags/case |
| 06971004782879 | Isolation Gown, L, 10 pieces/bag, 10 bags/case |
| 06971004784828 | Isolation Gown, L, 10 pieces/bag. 10 bags/case |
| 06971004784842 | Isolation Gown, XL, 10 pieces/bag, 10 bags/case |