Isolation Gown EasyRelease

GUDID 00634916790511

Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, Large, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White Non-Linting Cuffs and Cuff Shields

STANDARD TEXTILE CO., INC.

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• Primary Device ID: 00634916790511
• NIH Device Record Key: 8a2b9d29-fee5-4160-9f60-4694c3597b60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolation Gown EasyRelease
• Version Model Number: 661Y2635
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916790511 [Primary]

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: 2022-08-08
• Device Publish Date: 2022-07-29

On-Brand Devices [Isolation Gown EasyRelease]

• 00634916790511: Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, Large, Velcro Hook & Loop C
• 00634916790528: Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, XL, Velcro Hook & Loop Clos