ZD Isolation Gown-C

GUDID 06971004783135

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

Xuchang Zhengde Environstar Medical Products Co., Ltd.

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• Primary Device ID: 06971004783135
• NIH Device Record Key: d4633047-8cb8-4392-b258-db97c590b07a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZD Isolation Gown-C
• Version Model Number: ZDB120018
• 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: false
• 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	06971004783128 [Primary]
GS1	06971004783135 [Package]; Contains: 06971004783128; 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: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [ZD Isolation Gown-C]

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