SRI Healthcare 8604A

GUDID 00810019801556

Gown, Compel L3 XL, 20-Pk NS

SRI Healthcare, LLC

Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable

• Primary Device ID: 00810019801556
• NIH Device Record Key: 25a736f9-d5f4-41c6-b1ef-452740586caa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRI Healthcare
• Version Model Number: 8604
• Catalog Number: 8604A
• Company DUNS: 117798086
• Company Name: SRI Healthcare, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com
• Phone: 8138919550
• Email: customerservice@novohealthservices.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810019801556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041541

FDA Product Code

• FYA: Gown, Surgical

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: 2021-07-02
• Device Publish Date: 2021-06-24

On-Brand Devices [SRI Healthcare]

• 00810019801570: Basic Pack, Towel
• 00810019801563: Basic Pack, Linen
• 00810019801556: Gown, Compel L3 XL, 20-Pk NS
• 00810019801549: Gown, Compel L3 LG, 24-Pk NS
• 00810019801594: Wrapper, L2, 30x30" 20-Pk NS
• 00810019801501: Wrapper, L2, 30x30" 20-Pk NS
• 00810019801600: Basic Set Up Pack
• 00810019800399: NICU Pack, Vidant East Care
• 00810019801617: Cover, Back Table, M
• 00810019801624: Dental Pack
• 00810019801532: Wrapper, L2, 54x54" 10-Pk NS
• 00810019801525: Wrapper, L2, 45x45" 20-Pk NS
• 00810019801518: Wrapper, L2, 36x36" 20-Pk NS
• 00810019801587: Hip Pack, Total Flaget
• 00810019801648: Sleeve, Surgical L4, 2-Pack
• 00810019801662: Blanket, Delivery
• 00810019801631: Set Up Pack, Basin
• 00810019801686: Misc. Pack
• 00810019801679: Basin Set
• 00810019801860: Set Up, Arteriogram