FDA.reportPublic FDA data

PRIMUS Sterilizer

Primary DI
00850005738138
Brand
PRIMUS Sterilizer
Company
Primus Sterilizer Company, LLC
Model
PSS8-A-M
Device description
Steam Sterilizer, Healthcare, A
Published
2019-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093333000PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8Primus Sterilizer Company, LLC2010-04-02FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005738138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005738138008500057381388500057381380850005738138

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
402-344-4200xxx@xx.xx

Regulatory Flags#

DUNS number
825069404
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005738251PRIMUS Steam SterilizerPSS11-HA2024-05-15
00850005738268PRIMUS Steam SterilizerPSS11-HB2024-05-15
00850005738244Primus SterlizerPSS11-HC2023-12-14
00850005738008PRIMUS SterilizerPSS5-AA-M2019-02-25
00850005738015PRIMUS SterilizerPSS5-A-M2019-03-05
00850005738022PRIMUS SterilizerPSS5-B-M2019-03-05
00850005738039PRIMUS SterilizerPSS5-C-M2019-03-05
00850005738046PRIMUS SterilizerPSS5-D-M2019-03-05
00850005738053PRIMUS SterilizerPSS5-E-M2019-03-05
00850005738060PRIMUS SterilizerPSS5-F-M2019-03-05
00850005738077PRIMUS SterilizerPSS5-G-M2019-03-05
00850005738084PRIMUS SterilizerPSS5-G1-M2019-03-05
00850005738091PRIMUS SterilizerPSS5-J-M2019-03-05
00850005738107PRIMUS SterilizerPSS5-K-M2019-03-05
00850005738114PRIMUS SterilizerPSS5-M-M2019-03-05
00850005738121PRIMUS SterilizerPSS8-AA-M2019-03-05
00850005738145PRIMUS SterilizerPSS8-B-M2019-03-05
00850005738152PRIMUS SterilizerPSS8-C-M2019-03-05
00850005738169PRIMUS SterilizerPSS8-D-M2019-03-05
00850005738176PRIMUS SterilizerPSS8-E-M2019-03-05

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