FDA.reportPublic FDA data

AN1087 Dosimeter, Chemical Indicator

Primary DI
05060485030423
Brand
AN1087 Dosimeter, Chemical Indicator
Company
ANDERSEN STERILIZERS INC.
Model
AN1087.16
Catalog number
AN1087.16
Device description
AN1087.16 Dosimeter, Chemical Indicator, 16 units
Published
2018-09-01
Public version status
Update
Distribution status
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
K150645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150645000AN1087 DosimeterAndersen Sterilizers, Inc.2015-11-19JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060485030423PrimaryGS10
05060485030485Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060485030423050604850304235060485030423
05060485030485050604850304855060485030485

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
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-523-1276customerservice@anpro.com

Regulatory Flags#

DUNS number
931853006
Device count
16
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
05060485030683AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour ExposureAN1036.00AN1036.002023-08-31
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05