Primus Sterlizer

GUDID 00850005738244

PRIMUS Healthcare Sterilizer (Model PSS11-HC)

Primus Sterilizer Company, LLC

Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer

• Primary Device ID: 00850005738244
• NIH Device Record Key: 02ddf780-7fa6-4a48-ba33-431aa5df76cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primus Sterlizer
• Version Model Number: PSS11-HC
• 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: true

Customer Support Contacts

• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx
• Phone: 402.344.4200
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005738244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221474

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: 2023-12-22
• Device Publish Date: 2023-12-14

Devices Manufactured by Primus Sterilizer Company, LLC

• 00850005738251 - PRIMUS Steam Sterilizer: 2024-05-23 PRIMUS Steam Sterilizer ,Healthcare (Model PSS11-HA)
• 00850005738268 - PRIMUS Steam Sterilizer: 2024-05-23 PRIMUS Steam Sterilizer ,Healthcare (Model PSS11-HB)
• 00850005738244 - Primus Sterlizer: 2023-12-22PRIMUS Healthcare Sterilizer (Model PSS11-HC)
• 00850005738244 - Primus Sterlizer: 2023-12-22 PRIMUS Healthcare Sterilizer (Model PSS11-HC)
• 00850005738015 - PRIMUS Sterilizer: 2019-03-13 Steam Sterilizer, Healthcare, A
• 00850005738022 - PRIMUS Sterilizer: 2019-03-13 Steam Sterilizer, Healthcare, B
• 00850005738039 - PRIMUS Sterilizer: 2019-03-13 Steam Sterilizer, Healthcare, C
• 00850005738046 - PRIMUS Sterilizer: 2019-03-13 Steam Sterilizer, Healthcare, D
• 00850005738053 - PRIMUS Sterilizer: 2019-03-13 Steam Sterilizer, Healthcare, E