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 |