FDA.reportPublic FDA data

AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure

Primary DI
05060485030683
Brand
AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure
Company
ANDERSEN STERILIZERS INC.
Model
AN1036.00
Catalog number
AN1036.00
Device description
Indicator, sterilization process, 14 count
Published
2023-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K200334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200334000AN1036 DosimeterAndersen Sterilizers, Inc.2020-11-12JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060485030683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060485030683050604850306835060485030683

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 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
931853006
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060485030782AN2300.50 Tyvek Pouch, 50 countAN2300.50AN2300.502025-12-12
05060485030676AN87 Dosimeter, Chemical IndicatorAN87.14AN87.142020-08-14
05060485030263AN85 EO Indicator, Type 1 Process IndicatorAN85.00AN85.002018-09-01
05060485030270AN86 EO Indicator, Type 1 Process IndicatorAN86.00AN86.002018-09-01
05060485030294AN1087 Dosimeter, Chemical IndicatorAN1087.00AN1087.002018-09-01
05060485030423AN1087 Dosimeter, Chemical IndicatorAN1087.16AN1087.162018-09-01
05060485030706AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115VAN4000.60AN4000.602023-08-31
05060485030713AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230VAN4000.61AN4000.612023-08-31
05060485030737AN4000.66 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 120VAN4000.66AN4000.662023-08-31
05060485030744AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230VAN4000.67AN4000.672023-08-31
05060485030607Anprolene AN75 Ethylene Oxide SterilizerAN75.64AN75.642020-08-14
05060485030614Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VAN75.65AN75.652020-08-14
05060485030621Anprolene AN75 Ethylene Oxide Sterilizer, 115VAN75.74AN75.742020-08-14
05060485030638Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VAN75.75AN75.752020-08-14
05060485030669Anprolene AN75 Refill Kit, 14 UnitsAN7514.00AN7514.002020-08-14
05060485030164 EOGas 4 Refill KitAN1004.00AN1004.002018-09-01
05060485030331AN1071 HumidichipAN1071.00AN1071.002018-09-01
05060485030393EOGas 4 Ethylene Oxide Gas SterilizerAN4000.01AN4000.012018-09-01
05060485030409EOGas 4 Ethylene Oxide Gas SterilizerAN4000.11 AN4000.11 2018-09-01
05060485030416EOGas 4 Sterilization BagAN1004.99AN1004.992018-09-01

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