Full Coverage Isolation Gown #RR-300FC

GUDID 20813360023046

ICP MEDICAL, LLC

Surgical/examination garment kit

• Primary Device ID: 20813360023046
• NIH Device Record Key: 796d0eed-c96f-48d6-999e-e8216e8fc6e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full Coverage Isolation Gown #RR-300FC
• Version Model Number: 1
• Company DUNS: 078780963
• Company Name: ICP MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00813360023042 [Primary]
GS1	10813360023049 [Package]; Contains: 00813360023042; Package: Bag [10 Units]; In Commercial Distribution
GS1	20813360023046 [Package]; Contains: 10813360023049; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160361

FDA Product Code

• FYC: Gown, Isolation, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-04

Devices Manufactured by ICP MEDICAL, LLC

• 00068162000511 - Protexter: 2023-11-08 Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, 2XL
• 10688162000464 - ICP: 2023-10-13 Stretcher Sheet, White, SMS 96x37
• 00688162000481 - ICP: 2023-09-21 Stretcher Sheet, White, SMS 108x51
• 00688162384512 - Protexer: 2023-06-14 Bouffant Cap, Blue, 23"
• 10813360023407 - Protexter: 2022-11-17 Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, Universal
• 10688162000044 - Protexer: 2022-11-08 Impervious Boot Cover, Knee High, Non-Conductive, Universal
• 10688162000051 - Protexer: 2022-11-08 Bouffant Cap, Blue, 21"
• 10688162124009 - Protexer: 2022-11-08 Extra Protection Bouffant Cap, 24"