ICP RR-300XL

GUDID 00813360021482

30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist

ICP MEDICAL, LLC

Isolation gown, single-use

• Primary Device ID: 00813360021482
• NIH Device Record Key: 945f2116-8a77-4e53-a620-6e93baaca5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICP
• Version Model Number: 1
• Catalog Number: RR-300XL
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00813360021482 [Primary]
GS1	10813360021489 [Package]; Package: Bag [10 Units]; In Commercial Distribution
GS1	20813360021486 [Package]; Contains: 10813360021489; Package: case [10 Units]; In Commercial Distribution

FDA Product Code

• FME: Gown, Examination

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: 2020-06-12
• Device Publish Date: 2020-06-04

On-Brand Devices [ICP]

• 00813360021499: 30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist
• 00813360021482: 30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist
• 10813360021625: Universal Mattress Cover
• 10813360021632: 2XXL White Universal Mattress Cover
• 00688162000481: Stretcher Sheet, White, SMS 108x51
• 10688162000464: Stretcher Sheet, White, SMS 96x37