FDA.reportPublic FDA data

VERIFY

Primary DI
00724995172237
Brand
VERIFY
Company
ALBERT BROWNE LIMITED
Model
RK019
Catalog number
RK019
Device description
The VERIFY Steam and EO Load Record Cards document load contents and confirm the load has been processed.
Published
2020-05-29
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
K061738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061738000ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARDAlbert Browne , Ltd.2006-08-25JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995096714PreviousGS10
10724995172234PrimaryGS10
00724995172237Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499509671410724995096714
1072499517223410724995172234
00724995172237007249951722377249951722370724995172237

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. 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 Temperature32 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
100
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
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00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
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