Hackensack Meridian Health

GUDID 00840216125889

GOWN, HACKENSACK ISOLATION AAMI LV2, XLARGE, HANDS LOGO, OVER THE HEAD, THUMBLOOP W/ELASTIC WRIST, 10EA/BG, 10BG/CS (100EA/CS)

Asp Global, LLC

Isolation gown, single-use

• Primary Device ID: 00840216125889
• NIH Device Record Key: 3f317c81-6163-4b6a-b1d7-3820d11f1cd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hackensack Meridian Health
• Version Model Number: HKGNA451L2
• Company DUNS: 080361159
• Company Name: Asp Global, LLC
• 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: 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	00840216125889 [Primary]

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2024-02-06
• Device Publish Date: 2024-01-29

On-Brand Devices [Hackensack Meridian Health ]

• 00840216125896: GOWN, HACKENSACK ISOLATION AAMI LV2, UNIVERSAL, HANDS LOGO, OVER THE HEAD, THUMBLOOP W/ELASTIC W
• 00840216125889: GOWN, HACKENSACK ISOLATION AAMI LV2, XLARGE, HANDS LOGO, OVER THE HEAD, THUMBLOOP W/ELASTIC WRIS