ZD Isolation Gown-C

GUDID 06971004783111

Isolation Gown, L, 10 pieces/bag, 10 bags/case

Xuchang Zhengde Environstar Medical Products Co., Ltd.

Isolation gown, single-use
Primary Device ID06971004783111
NIH Device Record Key4ce18969-7a0a-4157-89a5-a6c1362353fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameZD Isolation Gown-C
Version Model NumberZDB120017
Company DUNS421272799
Company NameXuchang Zhengde Environstar Medical Products Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106971004783104 [Primary]
GS106971004783111 [Package]
Contains: 06971004783104
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [ZD Isolation Gown-C]

06971004783135Isolation Gown, XL, 10 pieces/bag, 10 bags/case
06971004783111Isolation Gown, L, 10 pieces/bag, 10 bags/case

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.