FDA.reportPublic FDA data

Getinge 500 Series

Primary DI
05902533549597
Brand
Getinge 500 Series
Company
GETINGE IC PRODUCTION POLAND SP Z O O
Model
533HC
Catalog number
5SSAUPHRA1AA
Device description
STEAM STERILIZER HC - 533HC-E,L1,SD,208 VPS BRASS,DU,PWR,R+2,REC,208/BD
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K122071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122071000GETINGE 400HC-E / SERIES STEAM STERILIZERGetinge Sourcing, LLC2013-03-12FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902533549597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902533549597059025335495975902533549597

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.

Regulatory Flags#

DUNS number
427370513
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902533549511Getinge 500 Series533HC5SDUUPHTAAAA 2026-05-15
05902533549214Getinge 500 Series533HC5SSPUPHTABAA2026-02-16
05902533549115Getinge 500 Series533HC5SSVUPHRTATA2026-01-16
05902533549122Getinge 500 Series533HC5SSVUPHRA3AA2026-01-16
05902533548842Getinge 500 Series533HC5SSVUMHTAZAA2025-08-15
05902533548828Getinge 500 Series533HC5SSPUMHRTDAA2025-08-08
05902533548835Getinge 500 Series533HC5SDPUMHRTDAA2025-08-08
05902533548873Getinge 500 Series533HC5SDPUMHRTAAA2025-08-08
05902533549023Getinge 500 Series533HC5SSPUMHRTAAA2025-08-08
05902533548804Getinge 700 Series733HC7SRRUPHTAAAA2025-06-13
05902533548798Getinge 500 Series533HC5SDPRPHRAAAA2025-04-11
05902533548774Getinge 500 Series533HC5SSPUPHRABAA2025-03-14
05902533548781Getinge 500 Series533HC5SDPUPHRABAA2025-03-14
05902533548767Getinge 500 Series533HC5SSPUPHRAFAA2024-11-15
05902533548750Getinge 500 Series533HC5SSPUMHRALAA2024-09-13
05902533511792Getinge 800 Series833HC8SFPRTHPAAAA2021-08-13
05902533511808Getinge 800 Series833HC8SEPRTHPAAAA2021-08-13
05902533511761Getinge 800 Series833HC8SRPUTHPAAAA2021-07-09
05902533511778Getinge 800 Series833HC8SLPUTHPAAAA2021-07-09
05902533511716Getinge 800 Series833HC8MFPUGHPAAAA2021-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995364168AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364175AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364182AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364199AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364205AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364212AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364229AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364236AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364243AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364250AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364267AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364274AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364281AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364298AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364304AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364311AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364328AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364335AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364342AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364359AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364366AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364373AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364380AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364397AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364557AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995368562AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12
06972615108058icanclaveNingbo Ican Machines Co., Ltd.FLE2026-04-26