FDA.reportPublic FDA data

Reliance

Primary DI
50724995083774
Brand
Reliance
Company
STERIS CORPORATION
Model
D5100
Catalog number
D5100
Device description
The Reliance DG Dry Germicide is a single-use dry germicide used only in the Reliance EPS Endoscope Processing System. The net contents are 272g per cup.
Published
2016-09-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZAAccessories, germicide, cleaning, for endoscopes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZAAccessories, Germicide, Cleaning, For EndoscopesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040049000THE RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2004-12-17NZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995083774PackageGS14In Commercial Distribution
10724995083776PrimaryGS10
00724995083779Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499508377450724995083774
1072499508377610724995083776
00724995083779007249950837797249950837790724995083779

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on a medical device (e.g., surgical or dental instrument) and/or facility surface; it may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight272Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep upright, dry, and in a clean environment. Avoid extreme heat and humidity
Special Storage Condition, Specify00Keep upright, dry, and in a clean environment. Avoid extreme heat and humidity.
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature16 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828222781
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00724995193669RelianceCorporation Steris CanadaNZA2020-09-04
00724995193676RelianceCorporation Steris CanadaNZA2020-09-04
00724995193683RelianceCorporation Steris CanadaNZA2020-09-04
00724995193690RelianceCorporation Steris CanadaNZA2020-09-04
00724995193706RelianceCorporation Steris CanadaNZA2020-09-04
00724995194420NACorporation Steris CanadaNZA2020-04-30
04961333243044N/APENTAX OF AMERICA, INC.NZA2018-03-12
04961333243051N/APENTAX OF AMERICA, INC.NZA2018-03-12
00724995002619NACorporation Steris CanadaNZA2017-04-15
00724995000639NACorporation Steris CanadaNZA2016-09-13
00724995001544NACorporation Steris CanadaNZA2016-09-13
00724995001551NACorporation Steris CanadaNZA2016-09-13
00724995087883NACorporation Steris CanadaNZA2016-09-13
00724995087890NACorporation Steris CanadaNZA2016-09-13
00724995087906NACorporation Steris CanadaNZA2016-09-13
00724995087913NACorporation Steris CanadaNZA2016-09-13
00724995087920NACorporation Steris CanadaNZA2016-09-13
00724995090630NACorporation Steris CanadaNZA2016-09-13
00724995152178RelianceCorporation Steris CanadaNZA2016-09-13
10724995083776RelianceSTERIS CORPORATIONNZA2016-09-08