PRIMUS Steam Sterilizer

GUDID 00850005738251

PRIMUS Steam Sterilizer ,Healthcare (Model PSS11-HA)

Primus Sterilizer Company, LLC

Steam sterilizer

• Primary Device ID: 00850005738251
• NIH Device Record Key: 0f49c1f6-316b-4ea2-876e-2d4e8917fbf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMUS Steam Sterilizer
• Version Model Number: PSS11-HA
• Company DUNS: 825069404
• Company Name: Primus Sterilizer Company, 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: 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

Customer Support Contacts

• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx
• Phone: 4023444200
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005738251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233132

FDA Product Code

• FLE: Sterilizer, Steam

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: 2024-05-23
• Device Publish Date: 2024-05-15

On-Brand Devices [PRIMUS Steam Sterilizer]

• 00850005738268: PRIMUS Steam Sterilizer ,Healthcare (Model PSS11-HB)
• 00850005738251: PRIMUS Steam Sterilizer ,Healthcare (Model PSS11-HA)