Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)

GUDID 20860008925712

Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)

Gredale LLC

Isolation gown, single-use

• Primary Device ID: 20860008925712
• NIH Device Record Key: 37207be9-eec5-4fba-89d2-12a39980e153
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)
• Version Model Number: GRE2000-XL
• Company DUNS: 079303209
• Company Name: Gredale LLC
• Device Count: 10
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com
• Phone: (323) 210-3951
• Email: shop@gredale.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008925718 [Unit of Use]
GS1	10860008925715 [Primary]
GS1	20860008925712 [Package]; Contains: 10860008925715; 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: 2022-07-20
• Device Publish Date: 2022-07-12

Devices Manufactured by Gredale LLC

• 20860008925729 - Gredale USA-Made AAMI Level 1 Isolation Gown (Large): 2022-08-31 Gredale USA-Made AAMI Level 1 Isolation Gown (Large)
• 20860008925736 - Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large): 2022-08-31 Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large)
• 20860008925743 - Gredale USA-Made AAMI Level 3 Surgical Gown (Large): 2022-08-31 Gredale USA-Made AAMI Level 3 Surgical Gown (Large)
• 20860008925750 - Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large): 2022-08-31 Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)
• 20860008925705 - Gredale USA-Made AAMI Level 2 Isolation Gown (Large): 2022-07-20 Gredale USA-Made AAMI Level 2 Isolation Gown (Large)
• 20860008925712 - Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large): 2022-07-20Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)
• 20860008925712 - Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large): 2022-07-20 Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)