Polycoated Protective Gown

GUDID 00850015055096

ULINE, INC.

Isolation gown, single-use

• Primary Device ID: 00850015055096
• NIH Device Record Key: 19fdf4fe-5b99-44ee-80de-25534ac38596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polycoated Protective Gown
• Version Model Number: S-17099
• Company DUNS: 039612668
• Company Name: ULINE, INC.
• Device Count: 50
• 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	00850015055096 [Unit of Use]
GS1	10850015055093 [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: 2021-03-03
• Device Publish Date: 2021-02-23

Devices Manufactured by ULINE, INC.

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• 30850015055516 - ULINE REUSABLE EARPLUGS - CORDED: 2024-08-02
• 30850015055523 - ULINE BULLET EARPLUGS - UNCORDED: 2024-07-31
• 30850015055530 - ULINE BULLET EARPLUGS - CORDED: 2024-07-31
• 30850015055547 - ULINE BELL EARPLUGS - UNCORDED: 2024-07-31
• 30850015055554 - ULINE BELL EARPLUGS - CORDED: 2024-07-31
• 30850015055493 - ULINE BULLET EARPLUGS REFILL: 2024-05-21
• 00850015055713 - ULINE EARPLUGS IN A BUCKET: 2024-05-21