ANDERSEN STERILIZERS INC.

Address:3154 Caroline Dr,Haw River,NC,27258,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sterilizer, Ethylene-Oxide Gas (FLF) (6) Indicator, Physical/Chemical Sterilization Process (JOJ) (4)

Premarket Exempt

Clear

EOGas 4 Refill Kit - 05060485030164 Catalog Number : AN1004.00

Device Description : AN1004.00 EOGas 4 Refill Kit, 25 EO 17.6g cartridges, 25 AN1087 Dosimeters, 25 H AN1004.00 EOGas 4 Refill Kit, 25 EO 17.6g cartridges, 25 AN1087 Dosimeters, 25 Humidichips, 26 EOGas 4 sterilization bags

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

AN85 EO Indicator, Type 1 Process Indicator - 05060485030263 Catalog Number : AN85.00

Device Description : AN85.00 EO Indicator, Type 1 Process Indicator, 200 units

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

AN86 EO Indicator, Type 1 Process Indicator - 05060485030270 Catalog Number : AN86.00

Device Description : AN86.00 EO Indicator, Type 1 Process Indicator, 200 units

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

AN1087 Dosimeter, Chemical Indicator - 05060485030294 Catalog Number : AN1087.00

Device Description : AN1087.00 Dosimeter, Chemical Indicator, 25 units

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 25

AN1071 Humidichip - 05060485030331 Catalog Number : AN1071.00

Device Description : AN1071.00 Humidichip, 25 units

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 25

EOGas 4 Ethylene Oxide Gas Sterilizer - 05060485030393 Catalog Number : AN4000.01

Device Description : AN4000.01 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

EOGas 4 Ethylene Oxide Gas Sterilizer - 05060485030409 Catalog Number : AN4000.11

Device Description : AN4000.11 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

EOGas 4 Sterilization Bag - 05060485030416 Catalog Number : AN1004.99

Device Description : AN1004.99 EOGas 4 Sterilization Bag, 17/roll

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 17

AN1087 Dosimeter, Chemical Indicator - 05060485030423 Catalog Number : AN1087.16

Device Description : AN1087.16 Dosimeter, Chemical Indicator, 16 units

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 16

AN1071 Humidichip - 05060485030430 Catalog Number : AN1071.16

Device Description : AN1071.16 Humidichip, 16 units

Device Class :

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 16

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