FDA.reportPublic FDA data

RELIANCE

Primary DI
00724995229528
Brand
RELIANCE
Company
STERIS CORPORATION
Model
Reliance 6500
Catalog number
REL650012EM
Device description
RELIANCE 6500 Series HEPA Filter Drying Cabinet, 12 Scope Expansion Unit is designed to help you manage access to your endoscope inventory, track key parameters, and easily access vertically hanging endoscopes, all in an organized and controlled drying environment.
Published
2024-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUPEndoscope maintenance system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUPEndoscope Maintenance SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995229528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995229528007249952295287249952295280724995229528

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope drying/storage cabinetAn electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37ยบ Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828222781
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995216504NACorporation Steris CanadaPUP2026-01-14
00724995245504RELIANCESTERIS CORPORATIONPUP2025-10-21
00724995226664NACorporation Steris CanadaPUP2025-04-04
00724995231453AMSCOCorporation Steris CanadaPUP2025-04-04
00724995232184NASTERIS CORPORATIONPUP2025-03-31
00724995232191NASTERIS CORPORATIONPUP2025-03-31
00724995232207NASTERIS CORPORATIONPUP2025-03-31
00724995232214NASTERIS CORPORATIONPUP2025-03-31
00724995232221NASTERIS CORPORATIONPUP2025-03-31
00724995232238NASTERIS CORPORATIONPUP2025-03-31
00724995232245NASTERIS CORPORATIONPUP2025-03-31
00816185001080EndoCabTorvan Medical IncPUP2024-11-29
00816185001097EndoCabTorvan Medical IncPUP2024-11-29
00816185001103EndoCabTorvan Medical IncPUP2024-11-29
00816185001110EndoCabTorvan Medical IncPUP2024-11-29
00724995224905NACorporation Steris CanadaPUP2024-11-25
00724995224912NACorporation Steris CanadaPUP2024-11-25
00724995229962RELIANCESTERIS CORPORATIONPUP2024-11-25
00724995229504RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229511RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229535RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229597RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229665RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229672RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229689RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229696RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229702RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229719RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229726RELIANCESTERIS CORPORATIONPUP2024-10-02
00724995229740RELIANCESTERIS CORPORATIONPUP2024-10-02