ComPel Isolation Gown, EasyRelease

GUDID 00634916791181

ComPel Isolation Gown, EasyRelease, AAMI Level 2, Yellow, XL, Bound Neck, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White Non-Linting Cuffs and Cuff Shields, RFID Chip

STANDARD TEXTILE CO., INC.

Isolation gown, reusable

• Primary Device ID: 00634916791181
• NIH Device Record Key: e78b38ae-c1f0-478e-8073-29b7a535529b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Isolation Gown, EasyRelease
• Version Model Number: 661Y2644
• 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	00634916791181 [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

Devices Manufactured by STANDARD TEXTILE CO., INC.

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• 00634916788105 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788112 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788129 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER