ZD Isolation Gown-CP

GUDID 06971004784828

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

Xuchang Zhengde Environstar Medical Products Co., Ltd.

Isolation gown, single-use

• Primary Device ID: 06971004784828
• NIH Device Record Key: 0e2b64de-853c-4eb0-947e-aeac24c59281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZD Isolation Gown-CP
• Version Model Number: ZDB120034A
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971004784811 [Primary]
GS1	06971004784828 [Package]; Contains: 06971004784811; Package: case [10 Units]; In Commercial Distribution

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [ZD Isolation Gown-CP]

• 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