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) (7) Indicator, Physical/Chemical Sterilization Process (JOJ) (1)

Premarket Exempt

Clear

EOGas 4 Refill Kit - 05060485030447 Catalog Number : AN1004.16

Device Description : AN1004.16 EOGas 4 Refill Kit, IATA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters AN1004.16 EOGas 4 Refill Kit, IATA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

EOGas 4 Refill Kit - 05060485030454 Catalog Number : AN1004.01

Device Description : AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

Anprolene AN75 Ethylene Oxide Sterilizer - 05060485030607 Catalog Number : AN75.64

Device Description : AN75.64 - Anprolene AN75 Sterilizer, 115V

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V - 05060485030614 Catalog Number : AN75.65

Device Description : AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

Anprolene AN75 Ethylene Oxide Sterilizer, 115V - 05060485030621 Catalog Number : AN75.74

Device Description : Anprolene AN75 Ethylene Oxide Sterilizer, 115V

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V - 05060485030638 Catalog Number : AN75.75

Device Description : Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

Anprolene AN75 Refill Kit, 14 Units - 05060485030669 Catalog Number : AN7514.00

Device Description : Anprolene AN75 Refill Kit, 14 Units - 14 EO 17.6g cartridges, 14 AN87 Dosimeters Anprolene AN75 Refill Kit, 14 Units - 14 EO 17.6g cartridges, 14 AN87 Dosimeters, 15 AN75 liner bags

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : FLF

Prescription Use : No

Device Count : 1

AN87 Dosimeter, Chemical Indicator - 05060485030676 Catalog Number : AN87.14

Device Description : AN87 Dosimeter, Chemical Indicator - 14 units

Device Class : 2

Duns Number: 931853006

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

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