VERIFY PCC029

GUDID 50724995087949

The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to an effective dose of peracetic acid. It is intended for use for routine monitoring of the Reliance EPS Endoscope Processing System employing Reliance DG Dry Germicide.

ALBERT BROWNE LIMITED

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator
Primary Device ID50724995087949
NIH Device Record Keye837aabd-a138-4cc7-9f8a-f039ea354801
Commercial Distribution Discontinuation2020-05-22
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERIFY
Version Model NumberPCC029
Catalog NumberPCC029
Company DUNS218172765
Company NameALBERT BROWNE LIMITED
Device Count60
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from direct light
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 43 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from direct light
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 43 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from direct light
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 43 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from direct light
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 43 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from direct light
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 43 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995087944 [Unit of Use]
GS100724995087944 [Unit of Use]
GS100724995087944 [Unit of Use]
GS100724995087944 [Unit of Use]
GS100724995087944 [Unit of Use]
GS110724995087941 [Primary]
GS110724995087941 [Primary]
GS110724995087941 [Primary]
GS110724995087941 [Primary]
GS110724995087941 [Primary]
GS150724995087949 [Package]
Contains: 10724995087941
Package: Box [2 Units]
Discontinued: 2020-05-22
In Commercial Distribution
GS150724995087949 [Package]
Contains: 10724995087941
Package: Box [2 Units]
Discontinued: 2020-05-22
Not in Commercial Distribution
GS150724995087949 [Package]
Contains: 10724995087941
Package: Box [2 Units]
Discontinued: 2020-05-22
In Commercial Distribution
GS150724995087949 [Package]
Contains: 10724995087941
Package: Box [2 Units]
Discontinued: 2020-05-22
In Commercial Distribution
GS150724995087949 [Package]
Contains: 10724995087941
Package: Box [2 Units]
Discontinued: 2020-05-22
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOJIndicator, physical/chemical sterilization process
JOJIndicator, physical/chemical sterilization process
JOJIndicator, physical/chemical sterilization process
JOJIndicator, physical/chemical sterilization process
JOJIndicator, physical/chemical sterilization process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-21
Device Publish Date2016-09-06

On-Brand Devices [VERIFY]

10724995091115The VERIFY Vaporized VH202 Process Indicator Adhesive Label is designed for use exclusively in t
10724995001848The VERIFY HPU Chemical Indicator is a vaporized hydrogen peroxide sterilization process indicat
10724995096714VERIFY Steam and EO Load Record Cards document load contents and confirm the load has been proce
50724995087949The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic aci

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