ComPel Isolation Gown

GUDID 01634916814520

EasyRelease, ComPel Isolation Gown, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closure at Neck, Tie Closure at Waist, Long Sleeves with Natural White Non-Linting Cuffs, size XL

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

• Primary Device ID: 01634916814520
• NIH Device Record Key: 14549bdb-8a54-4271-a027-3ef24c740a61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Isolation Gown
• Version Model Number: 661Y5044
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916814521 [Primary]
GS1	01634916814520 [Unit of Use]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

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

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

Moist Heat or Steam Sterilization

[01634916814520]

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