FDA.reportPublic FDA data

AMSCO

Primary DI
00724995176648
Brand
AMSCO
Company
Corporation Steris Canada
Model
7053HP
Catalog number
FH19082
Device description
AMSCO 7053HP Washer-Disinfector Steam Heated Unit delivers a validated and cleared process for cleaning reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers.
Published
2020-09-04
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
NVEWasher, cleaner, automated, endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2
NVEWasher, Cleaner, Automated, EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995176648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995176648007249951766487249951766480724995176648

Contacts#

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

Regulatory Flags#

DUNS number
202659140
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
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
00724995176709AMSCO7053HPFH190322019-08-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00724995214449AMSCOCorporation 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
00724995176563AMSCOCorporation Steris CanadaNVE2020-09-04
00724995192648Reliance VisionCorporation Steris CanadaMEC2020-09-04
00724995192655Reliance VisionCorporation Steris CanadaMEC2020-09-04
00724995192662Reliance VisionCorporation Steris CanadaMEC2020-09-04
00724995192679Reliance VisionCorporation Steris CanadaMEC2020-09-04
00724995192686Reliance VisionCorporation Steris CanadaMEC2020-09-04
00724995192761AMSCOCorporation Steris CanadaMEC2020-09-04
00724995192778AMSCOCorporation Steris CanadaMEC2020-09-04
00724995192785AMSCOCorporation Steris CanadaMEC2020-09-04