FDA.reportPublic FDA data

AMSCO

Primary DI
00724995176587
Brand
AMSCO
Company
Corporation Steris Canada
Model
7052HP
Catalog number
FH18042
Device description
The AMSCO 7052HP Washer-Disinfector with Steam Heat delivers a validated and cleared process for cleaning reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers.
Published
2019-08-06
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
00724995176587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995176587007249951765877249951765870724995176587

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
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
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
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
08051520020940SteelcoSTEELCO SPAMEC2025-05-05
08051520020797SteelcoSTEELCO SPAMEC2025-04-10
08051520018879SteelcoSTEELCO SPAMEC2024-09-12
08051520018589SteelcoSTEELCO SPAMEC2024-08-07
08051520017339SteelcoSTEELCO SPAMEC2024-06-11
08051520017162SteelcoSTEELCO SPAMEC2024-05-29
08051520015724SteelcoSTEELCO SPAMEC2023-12-21
08051520012518SteelcoSTEELCO SPAMEC2023-10-16
08051520012877SteelcoSTEELCO SPAMEC2023-10-16
07340153710344Getinge Aquadis 56Getinge Disinfection ABMEC2022-12-23
07340153710351Getinge Aquadis 56Getinge Disinfection ABMEC2022-12-23