FDA.reportPublic FDA data

AMSCO

Primary DI
00724995214449
Brand
AMSCO
Company
Corporation Steris Canada
Model
1215
Catalog number
FW12105
Device description
AMSCO 1215 Cart and Utensil Washer/Disinfector, 380-400V, 60hz, Steam Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers.
Published
2021-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
00724995214449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995214449007249952144497249952144490724995214449

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
202659140
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
00724995201807NAAcu-sInQ Leak Test7117185SKN2020-10-16
00724995201777NAAcu-sInQ Leak Test600832OKN2020-10-16
00724995201784NAAcu-sInQ Leak Test7117185FKN2020-10-16
00724995201791NAAcu-sInQ Leak Test7117185PKN2020-10-16
00724995176754NAFD024FD0242019-09-24
00724995150907NAFD026FD0262016-09-13
00724995151003NAFD111FD1112016-09-13
00724995151119NAFD70400FD704002016-09-13
00724995151195NAFD75500FD755002016-09-13
00724995151331NAFD81600FD816002016-09-13
00724995217433enspireenspire 300 SeriesENHLD300208VFD2024-04-17
00724995217440enspireenspire 300 SeriesENHLD300208VWD2024-04-17
00724995217457enspireenspire 300 SeriesENHLD300208NVFD2024-04-17
00724995217464enspireenspire 300 SeriesENHLD300208NVWD2024-04-17
00724995217471enspireenspire 300 SeriesENHLD300480VFD2024-04-17
00724995217488enspireenspire 300 SeriesENHLD300480VWD2024-04-17
00724995217495enspireenspire 300 SeriesENHLD300480NVFD2024-04-17
00724995217501enspireenspire 300 SeriesENHLD300480NVWD2024-04-17
00724995214395AMSCO1215FW121012021-08-13
00724995214401AMSCO1215FW121022021-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
00848530020118CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-28
00848530096564CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530020101CPAP CleaningSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530080525Germicidal Deodorizing CleanserSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530084813CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530087067CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
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
07340153710344Getinge Aquadis 56Getinge Disinfection ABMEC2022-12-23
00724995214395AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214401AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214418AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214425AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214432AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214456AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214463AMSCOCorporation Steris CanadaMEC2021-08-13
00724995214470AMSCOCorporation Steris CanadaMEC2021-08-13
10841736121167Skytron Acidic NeutralizerSKYTRON LLCMEC2021-06-16
10841736121174Skytron Acidic NeutralizerSKYTRON LLCMEC2021-01-15
10841736121181Skytron Acidic NeutralizerSKYTRON LLCMEC2021-01-15
10841736121198Skytron Acidic NeutralizerSKYTRON LLCMEC2021-01-15
10841736121204Skytron Acidic NeutralizerSKYTRON LLCMEC2021-01-15
00724995176563AMSCOCorporation Steris CanadaMEC2020-09-04