FDA.reportPublic FDA data

VERIFY

Primary DI
10724995087941
Brand
VERIFY
Company
ALBERT BROWNE LIMITED
Model
PCC029
Catalog number
PCC029
Device description
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.
Published
2016-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063285000RELIANCE CI PROCESS INDICATORAlbert Browne , Ltd.2007-01-12JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995087949PackageGS12Not in Commercial Distribution
10724995087941PrimaryGS10
00724995087944Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499508794950724995087949
1072499508794110724995087941
00724995087944007249950879447249950879440724995087944

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Keep away from direct light
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature43 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
218172765
Device count
60
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995220614VERIFYU504U5042025-12-17
00724995220617VERIFYU504U5042025-12-17
10724995087972VerifyLCC012LCC0122025-08-05
10724995087958VerifyLCC010LCC0102025-08-05
00724995087975VerifyLCC012LCC0122025-08-05
10724995231887VERIFYLCC027LCC0272025-05-29
00724995231897VERIFYLCC028LCC0282025-05-29
50724995231885VERIFYLCC027LCC0272025-05-29
10724995164741CelerityPCC0075PCC0752019-11-01
10724995172197VERIFYPCC029PCC0292020-05-29
10724995164734CelerityPCC074PCC0742020-04-10
10724995172180CelerityPCC076PCC0762019-06-14
10724995172234VERIFYRK019RK0192020-05-29
10724995218581CelerityPCC079PCC0792022-08-10
10724995092945VERIFYLCC016LCC0162016-09-06
10724995091108VERIFYPCC046PCC0462016-09-06
10724995084629VERIFYPCC005PCC0052016-09-06
10724995084636VERIFYPCC007PCC0072016-09-06
10724995084643VERIFYPCC008PCC0082016-09-06
10724995084650VERIFYPCC006PCC0062016-09-06

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Primary DI, Brand, Company table
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