FDA.reportPublic FDA data

Revital-Ox

Primary DI
50724995217360
Brand
Revital-Ox
Company
ALBERT BROWNE LIMITED
Model
PCC081
Catalog number
PCC081
Device description
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is used for the routine monitoring of enspire 300 Series Automated Endoscope Reprocessor employing Revital-Ox PAA High Level Disinfectant.
Published
2023-08-31
Public version status
New
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
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
K230558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230558000Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation2023-07-17JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995217360PackageGS12In Commercial Distribution
10724995217362PrimaryGS10
00724995217365Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499521736050724995217360
1072499521736210724995217362
00724995217365007249952173657249952173650724995217365

GMDN Terms#

Term, Definition table
TermDefinition
Peracetic acid device disinfectant/sterilant test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of peracetic acid in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). 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 Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature43 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
218172765
Device count
50
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
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
10724995087941VERIFYPCC029PCC0292016-09-06
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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