ComPel Isolation Gown

GUDID 01634916800721

EasyRelease Isolation Gown, Compel with Carbon, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White Non-Linting Cuffs and Cuff Shields, RFID Chip in Bottom Hem, size Large

STANDARD TEXTILE CO., INC.

Isolation gown, reusable

• Primary Device ID: 01634916800721
• NIH Device Record Key: c3108290-61f9-470f-9944-e5a7f3be29e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Isolation Gown
• Version Model Number: 661Y4965
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 48
• 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
• 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	00634916800722 [Primary]
GS1	01634916800721 [Unit of Use]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

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

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

[01634916800721]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-21
• Device Publish Date: 2021-06-11

On-Brand Devices [ComPel Isolation Gown]

• 01634916814520: EasyRelease, ComPel Isolation Gown, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closure at Neck
• 01634916803883: Isolation Gown, ComPel with Carbon, AAMI Level 2, Tie Closures Neck and Waist, Raglan Sleeves wi
• 01634916800721: EasyRelease Isolation Gown, Compel with Carbon, AAMI Level 2, Bound Neck, Velcro Hook & Loop Clo
• 10634916822158: ComPel Isolation Gown, AAMI Level 2, 100% Polyester, Yellow, Tie Closures Neck and Waist, Raglan
• 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