Protexter ICP-8150FC-XL

GUDID 00068162000511

Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, 2XL

ICP MEDICAL, LLC

Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use

• Primary Device ID: 00068162000511
• NIH Device Record Key: ae49ad39-6141-4a75-9d5c-2ed6296f2d76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protexter
• Version Model Number: 1
• Catalog Number: ICP-8150FC-XL
• Company DUNS: 078780963
• Company Name: ICP MEDICAL, 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00068162000511 [Primary]

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Protexter]

• 10813360021526: Universal Comfort Gown
• 10813360021649: Universal Comfort Gown
• 10813360021564: Universal Extended Wear Gown
• 10813360021670: Full Coverage
• 10813360021663: Universal Comfort Gown
• 10813360021656: Universal Comfort Gown
• 10813360021595: Universal Isolation Gown
• 10813360022059: Isolation Gown
• 10813360023407: Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, Universal
• 00068162000511: Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elasti