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 Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable Isolation gown, reusable 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

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