FDA.reportPublic FDA data

GETINGE 9100-SERIES

Primary DI
07340153710023
Brand
GETINGE 9100-SERIES
Company
Getinge Disinfection AB
Model
9120E
Catalog number
9120E-001
Device description
WASHER DISINFECTOR 9120E
Published
2017-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
07340153710023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340153710023073401537100237340153710023

GMDN Terms#

Term, Definition table
TermDefinition
Instrument chemical/thermal disinfectorAn electrically-powered unit intended to be used for both chemical and thermal disinfection of probes, surgical instruments, and/or endoscopes, and their accessories. It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; some types may also have built-in drying features. It is not intended for device sterilization.

Regulatory Flags#

DUNS number
354023236
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
07340153710344Getinge Aquadis 5656A2022-12-23
07340153710351Getinge Aquadis 5656M2022-12-23
07340153700147GETINGE 91-SERIES91229122-0022016-09-22
07340153700161GETINGE 91-SERIES91289128-0022016-09-22
07340153700246GETINGE 86-SERIESS-8666S-866620012016-09-22
07340153700253GETINGE 86-SERIESS-8666S-866620032016-09-22
07340153710030GETINGE 9100-SERIES9122EW9122EW-0012017-11-16
07340153710047GETINGE 9100-SERIES9125E9125E-0012017-11-16
07340153710054GETINGE 9100-SERIES9127E9127E-0012017-11-16
07340153710061GETINGE 9100-SERIES9128E9128E-0012017-07-10
07340153710078GETINGE 9100-SERIES9128EW9128EW-0012017-11-16
07340153710160GETINGE 46-SERIES46-446-4-402K9682017-03-06
07340153710191GETINGE 1600-SERIESFD1600FD1600-0012017-04-12
07340153710207GETINGE 1800-SERIESFD1800FD1800K902IP242017-04-12
07340153710214GETINGE 1800-SERIESFD1810FD1810-0012017-04-12
07340153710221GETINGE 1800-SERIESFD1810FD1810-001K9062017-04-12
07340153710238GETINGE 1800-SERIESFD1810FD1810-001K9212017-04-12
07340153710245GETINGE 600-SERIESS-607S-6070104SE022017-04-12
07340153710269Getinge 86-SeriesS-8668TS-8668T10012018-08-30
07340153710306GETINGE 6000TYPHOONSP6000AR0032017-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
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
08051520021176SteelcoSTEELCO SPAMEC2025-10-28
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
08051520021763SteelcoSTEELCO SPAMEC2025-09-16
08051520021473SteelcoSTEELCO SPAMEC2025-07-24
08051520021480SteelcoSTEELCO SPAMEC2025-07-24
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
04002516883838MieleMiele & Cie. KGMEC2025-07-01
04002516883845MieleMiele & Cie. KGMEC2025-07-01
04002516884781MieleMiele & Cie. KGMEC2025-07-01
04002516884927MieleMiele & Cie. KGMEC2025-07-01
04002516884934MieleMiele & Cie. KGMEC2025-07-01
08051520020957SteelcoSTEELCO SPAMEC2025-06-30
08051520021350SteelcoSTEELCO SPAMEC2025-06-18
08051520021190SteelcoSTEELCO SPAMEC2025-05-22
08051520021169SteelcoSTEELCO SPAMEC2025-05-08
08051520020940SteelcoSTEELCO SPAMEC2025-05-05
08051520020797SteelcoSTEELCO SPAMEC2025-04-10
08051520018879SteelcoSTEELCO SPAMEC2024-09-12
08051520018589SteelcoSTEELCO SPAMEC2024-08-07