Health Supply US Level 2 Gown HSUS-L2-EC-L

GUDID 00381342000751

Package of 10 single-use, non-sterile L2 SMS isolation gowns - gowns are not sold individually.

Health Supply US, LLC

Isolation gown, single-use

• Primary Device ID: 00381342000751
• NIH Device Record Key: 57a1de2e-ee2f-49a9-ac3e-044e348c96e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Supply US Level 2 Gown
• Version Model Number: HSUS-L2-EC-L
• Catalog Number: HSUS-L2-EC-L
• Company DUNS: 117465816
• Company Name: Health Supply US, LLC
• Device Count: 10
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381342000454 [Primary]
GS1	00381342000706 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	00381342000713 [Package]; Contains: 00381342000706; Package: Pallet [12 Units]; In Commercial Distribution
GS1	00381342000751 [Unit of Use]

FDA Product Code

• OEA: Non-Surgical 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: 2024-06-26
• Device Publish Date: 2024-06-18

On-Brand Devices [Health Supply US Level 2 Gown]

• 00381342000768: Pack of 10 L2 SMS non-sterile Isolation Gowns
• 00381342000799: Pack of 10 Level 2 non-sterile isolation gown
• 00381342000829: Pack of 10 Level 2 SMS non-sterile isolation gowns
• 00381342000744: Pack of 10 Level 2 non-sterile, single-use, isolation gowns - gowns are not sold individually
• 00381342000751: Package of 10 single-use, non-sterile L2 SMS isolation gowns - gowns are not sold individually.