FDA.reportPublic FDA data

NA

Primary DI
00724995151393
Brand
NA
Company
Corporation Steris Canada
Model
FD78000
Catalog number
FD78000
Device description
The Anesthesia Respiratory Rack is designed to be used in the washer disinfector for the efficient cleaning, rinsing, drying and intermediate Level disinfection of different types of anesthesia tubing, bags, masks and respiratory goods.
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00724995151393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995151393007249951513937249951513930724995151393

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rackA non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.

Sterilization Methods#

Method table
Method

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
false
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
00724995216504NAReliance 6000 ConnectorsRECT1CON7P2026-01-14
00724995226664NAReliance 6000 ConnectorsRECT1CON7F2025-04-04
00724995231453AMSCODrying Cabinet ConnectorDCT3CON01IN2025-04-04
00724995224905NAReliance 6000 ConnectorsRECT1CON6F2024-11-25
00724995224912NAReliance 6000 ConnectorsRECT1CON8F2024-11-25
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
00724995216511NAReliance 6000 ConnectorsRECT1CON8P2024-04-05
00724995225803NAFD372FD3722023-07-20
00724995218348NAFD053FD0532022-04-18
00724995218317NAFD050FD0502022-03-23
00724995218324NAFD051FD0512022-03-23
00724995218331NAFD052FD0522022-03-23
00724995216290AMSCODrying CabinetDCR100101XL2021-11-10

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Primary DI, Brand, Company table
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04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
10841736125141CleanStartSKYTRON LLCMEC2025-12-19
10841736125158CleanStartSKYTRON LLCMEC2025-12-19
10841736125165CleanStartSKYTRON LLCMEC2025-12-19
10841736125172CleanStartSKYTRON LLCMEC2025-12-19
10841736125189CleanStartSKYTRON LLCMEC2025-12-19
10841736125196CleanStartSKYTRON LLCMEC2025-12-19
10841736125202CleanStartSKYTRON LLCMEC2025-12-19
10841736125219CleanStartSKYTRON LLCMEC2025-12-19
00724995220617VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
10841736124427Sterling SKYTRON LLCMEC2025-12-09
10841736124434Sterling SKYTRON LLCMEC2025-12-09
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
00848530020118CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-28
00848530020101CPAP Cleaning SUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530080525 Germicidal Deodorizing CleanserSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530084813CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530087067CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
10848530096561CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
10724995087958VerifyALBERT BROWNE LIMITEDMEC2025-08-05
00724995087975VerifyALBERT BROWNE LIMITEDMEC2025-08-05
08051520021473SteelcoSTEELCO SPAMEC2025-07-24
08051520021480SteelcoSTEELCO SPAMEC2025-07-24
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-Disinfector Dent4You AGMEC2025-07-22