PACKARD HEALTHCARE ISOLATION GOWN L2 ELASTIC CUFF

GUDID D89260705534522

MAXILL, INC.

Isolation gown, single-use

• Primary Device ID: D89260705534522
• NIH Device Record Key: 321e9342-428e-4cc5-b552-3a1570e6d1b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACKARD HEALTHCARE ISOLATION GOWN L2 ELASTIC CUFF
• Version Model Number: 6070553452
• 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	D89260705534520 [Unit of Use]
HIBCC	D89260705534521 [Primary]
HIBCC	D89260705534522 [Package]; Contains: D89260705534521; 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 [PACKARD HEALTHCARE ISOLATION GOWN L2 ELASTIC CUFF]

• D89260705534532: 6070553453
• D89260705534522: 6070553452