FDA.reportPublic FDA data

GETINGE 9100-SERIES

Primary DI
07340153710030
Brand
GETINGE 9100-SERIES
Company
Getinge Disinfection AB
Model
9122EW
Catalog number
9122EW-001
Device description
WASHER DISINFECTOR 9122EW
Published
2017-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MECDisinfector, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340153710030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340153710030073401537100307340153710030

GMDN Terms#

Term, Definition table
TermDefinition
Surgical utensil washer/disinfectorA mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most instruments, especially those used invasively or in a sterile field will require sterilization after this process. It is typically located in rooms and central supply departments designed to handle soiled instruments/utensils. It typically includes internal baskets/racks in which the utensils are placed to ensure circulation of the heated water/detergents to all surfaces.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354023236
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340153711792Ultra Clean SystemsGetinge 1100 2026-05-11
07340153711808Ultra Clean SystemsGetinge 11012026-05-11
07340153715813Ultra Clean SystemsModel 1100 - Lumen tray only2026-05-11
07340153715820Ultra Clean SystemsModel 1101 - Lumen Tray only2026-05-11
07340153715868Ultra Clean SystemsXi RACS tray with adapters for Model 11012026-05-11
07340153715875Ultra Clean SystemsSP Tray with adapters - Model 11012026-05-11
07340153715936Ultra Clean SystemsModel 1100 - Lumen Tray with Accessory Kit2026-05-11
07340153715950Ultra Clean SystemsModel 1101 - Lumen Tray with Accessory kit2026-05-11
07340153715967Ultra Clean SystemsModel 1101 RACS tray with S and SI adapters2026-05-11
07340153715998Ultra Clean SystemsXi RACS tray with adapters for Model 11012026-05-11
07340153711815Ultra Clean SystemsGetinge 11502026-02-25
07340153711822Ultra Clean SystemsGetinge 15222026-02-25
07340153711839Ultra Clean SystemsGetinge Triton 36 2026-02-25
07340153711846Ultra Clean SystemsGetinge Triton 72 2026-02-25
07340153715837Ultra Clean SystemsBASKET ASSEMBLY, 1150, 1522 10-01552026-02-25
07340153715844Ultra Clean SystemsBASKET ASSEMBLY, TRITON 36, 72 10-01582026-02-25
07340153715851Ultra Clean SystemsROBOTIC ARM CLEANING BASKET 10-03122026-02-25
07340153715882Ultra Clean SystemsBASKET W/ADAPTER KIT, 36, 72 10-01582026-02-25
07340153715899Ultra Clean SystemsRACS BASKET, S/SI ADAPTERS 10-01582026-02-25
07340153715905Ultra Clean SystemsRACS BASKET, Xi ADAPTERS 10-03242026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
10841736125257Sterling WashersSKYTRON LLCMEC2026-04-26
08051520022876SteelcoSTEELCO SPAMEC2026-04-17
08051520022852SteelcoSTEELCO SPAMEC2026-03-27
08051520022869SteelcoSTEELCO SPAMEC2026-02-04
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
10841736125141CleanStartSKYTRON LLCMEC2025-12-19
10841736125158CleanStartSKYTRON LLCMEC2025-12-19
10841736125165CleanStartSKYTRON LLCMEC2025-12-19
10841736125172CleanStartSKYTRON LLCMEC2025-12-19
10841736125189CleanStartSKYTRON LLCMEC2025-12-19
10841736125196CleanStartSKYTRON LLCMEC2025-12-19
10841736125202CleanStartSKYTRON LLCMEC2025-12-19
10841736125219CleanStartSKYTRON LLCMEC2025-12-19
10724995220614VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
00724995220617VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
10841736124427Sterling SKYTRON LLCMEC2025-12-09
10841736124434Sterling SKYTRON LLCMEC2025-12-09
08051520021176SteelcoSTEELCO SPAMEC2025-10-28
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
08051520021763SteelcoSTEELCO SPAMEC2025-09-16
00848530020118CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-28
00848530096564CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530020101CPAP Cleaning SUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530080525 Germicidal Deodorizing CleanserSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530084813CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530087067CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27