NYES Protect4

GUDID 10860008955125

Disposable Isolation Gown, AAMI Level 2, Large by Coulmed

New York Embroidery Studio Inc.

Isolation gown, single-use

• Primary Device ID: 10860008955125
• NIH Device Record Key: 71d535d7-75ea-44c9-b9e6-f959327aaade
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NYES Protect4
• Version Model Number: NYES400-1
• Company DUNS: 152597766
• Company Name: New York Embroidery Studio Inc.
• Device Count: 1
• DM Exempt: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008955128 [Primary]
GS1	10860008955125 [Package]; Contains: 00860008955128; Package: [50 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: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [NYES Protect4]

• 10860008955132: Disposable Isolation Gown, AAMI Level 2, XLarge by Coulmed
• 10860008955125: Disposable Isolation Gown, AAMI Level 2, Large by Coulmed