ComPel Isolation Gown

GUDID 00634916797459

ComPel Isolation Gown, 100% POLYESTER.

STANDARD TEXTILE CO., INC.

Isolation gown, reusable

• Primary Device ID: 00634916797459
• NIH Device Record Key: 250e53e0-438a-4a82-a27c-103c94c52841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Isolation Gown
• Version Model Number: 6610359V
• 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916797459 [Primary]

FDA Product Code

• OEA: Non-Surgical Gown

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

[00634916797459]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-19
• Device Publish Date: 2026-03-11

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• 01634916800721: EasyRelease Isolation Gown, Compel with Carbon, AAMI Level 2, Bound Neck, Velcro Hook & Loop Clo
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• 00634916501681: ComPel Isolation Gown, AAMI Level 2, Yellow, 5XL, 100% Polyester, Plastic Snap Closure Neck, Col
• 00634916501674: ComPel Isolation Gown, AAMI Level 2, Yellow, 3XL, 100% Polyester, Plastic Snap Closure Neck, Col
• 00634916501667: ComPel Isolation Gown, AAMI Level 2, Yellow, XL, 100% Polyester, Plastic Snap Closure Neck, Colo
• 00634916857535: Isolation Gown, ComPel, Yellow, Raglan Sleeves, Metal Snaps at Neck and Waist, Elastic Sleeve
• 00634916797459: ComPel Isolation Gown, 100% POLYESTER.