AQUIST ISOLATION GOWN L2 KNIT CUFF

GUDID D89260705534562

MAXILL, INC.

Isolation gown, single-use

• Primary Device ID: D89260705534562
• NIH Device Record Key: 6088a89b-15ab-4cec-8c7c-e03314cd5bb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUIST ISOLATION GOWN L2 KNIT CUFF
• Version Model Number: 6070553456
• Company DUNS: 079343581
• Company Name: MAXILL, INC.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D89260705534560 [Unit of Use]
HIBCC	D89260705534561 [Primary]
HIBCC	D89260705534562 [Package]; Contains: D89260705534561; Package: CASE [100 Units]; In Commercial Distribution

FDA Product Code

• OEA: Non-Surgical Isolation 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: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [AQUIST ISOLATION GOWN L2 KNIT CUFF]

• D89260705534562: 6070553456
• D89260705534552: 6070553455