Generic Polyester Isolation Gown

GUDID 00634916785890

Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sleeve Opening and Thumb Loop, Size LG

STANDARD TEXTILE CO., INC.

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• Primary Device ID: 00634916785890
• NIH Device Record Key: 7f36084c-1958-486f-9ecc-a9c16a0e216c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Generic Polyester Isolation Gown
• Version Model Number: 666406F5
• 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
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916785890 [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: 2023-05-11
• Device Publish Date: 2023-05-03

On-Brand Devices [Generic Polyester Isolation Gown]

• 01634916801155: EasyRelease, Generic Polyester Isolation Gown, Bound Neck, Velcro Hook & Loop Closures at Neck/W
• 00634916785913: Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sl
• 00634916785906: Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sl
• 00634916785890: Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sl