FDA.reportPublic FDA data

Reliance Vision

Primary DI
00724995192648
Brand
Reliance Vision
Company
Corporation Steris Canada
Model
Single Chamber
Catalog number
FH05042
Device description
The Reliance Vision Single-Chamber Washer Disinfector, Steam Unit is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps), theater shoes and other similar and related items found in healthcare facilities.
Published
2020-09-04
Public version status
Update
Distribution status
Not 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
00724995192648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995192648007249951926487249951926480724995192648

GMDN Terms#

Term, Definition table
TermDefinition
Instrument non-thermal chemical disinfectorAn electrically-powered unit intended to be used for the non-thermal chemical disinfection of probes, surgical instruments, and/or endoscopes, and their accessories (e.g., heat-sensitive instruments). 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
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
00724995214418AMSCO1215FW121122021-08-13
00724995214425AMSCO1215FW121072021-08-13
00724995214432AMSCO1215FW121172021-08-13
00724995214449AMSCO1215FW121052021-08-13
00724995214456AMSCO1215FW121152021-08-13
00724995214463AMSCO1215FW121032021-08-13
00724995214470AMSCO1215FW121132021-08-13
00724995176563AMSCO7052HPFH180822020-09-04
00724995176648AMSCO7053HPFH190822020-09-04
00724995192655Reliance VisionSingle ChamberFH050432020-09-04

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