Protexer ICP-5050Y

GUDID 00813360021536

Isolation Polycoated Yellow Gown, With Elastic Wrist

ICP MEDICAL, LLC

Isolation gown, single-use

• Primary Device ID: 00813360021536
• NIH Device Record Key: 39e1b385-93d5-48f8-8b2c-5c2eef3fddcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protexer
• Version Model Number: 1
• Catalog Number: ICP-5050Y
• 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: 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
GS1	00813360021536 [Primary]
GS1	10813360021533 [Package]; Package: Bag [10 Units]; In Commercial Distribution
GS1	20813360021530 [Package]; Contains: 10813360021533; Package: Case [10 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: 2021-11-10
• Device Publish Date: 2021-11-02

On-Brand Devices [Protexer]

• 10813360021724: Chemotherapy Gown Universal, Purple
• 00813360021536: Isolation Polycoated Yellow Gown, With Elastic Wrist
• 00813360021611: SMS Medium Weight Full Coverage
• 10813360021557: Extended Wear Gown, PE Coated Material, With Knit Cuffs, Universal
• 10813360021588: SMS Material (28 GSM), Yellow Breathable/Fluid Resistant
• 10813360021571: Breathable, Extended Wear Full Coverage Gown, White W/PE Coating
• 10813360021373: Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuffs, 2XL
• 10813360021366: Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuffs, Universal
• 10813360021397: Isolation Gown, Polyethylene, Blue, Thumb Loop, Over the Head, Open Back, Universal
• 10813360021540: Isolation gown, Polycoated, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist,
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• 10688162124009: Extra Protection Bouffant Cap, 24"
• 10688162000051: Bouffant Cap, Blue, 21"
• 10688162000044: Impervious Boot Cover, Knee High, Non-Conductive, Universal
• 00688162384512: Bouffant Cap, Blue, 23"