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

GUDID 00381342000768

Pack of 10 L2 SMS non-sterile Isolation Gowns

Health Supply US, LLC

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• Primary Device ID: 00381342000768
• NIH Device Record Key: 668bcefd-b96d-4c19-b7e7-c1ee628844c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Supply US Level 2 Gown
• Version Model Number: HSUS-L2-EC-S
• Catalog Number: HSUS-L2-EC-S
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00381342000591 [Primary]
GS1	00381342000768 [Unit of Use]
GS1	00381342000775 [Package]; Contains: 00381342000591; Package: Case [10 Units]; In Commercial Distribution
GS1	10381342000772 [Package]; Contains: 00381342000775; Package: Pallet [12 Units]; In Commercial Distribution

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.