TYPENEX MEDICAL LLC

Address:303 E Wacker Dr Ste 1030,Chicago,IL,60601,US

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Filters

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

Anesthesia Breathing Circuit Kit (Adult & Pediatric) (OFP) (6) Condenser, Heat And Moisture (Artificial Nose) (BYD) (2) Tubing, Pressure And Accessories (BYX) (2)

Premarket Exempt

No Yes

Clear

ARC Medical - 00810050853873 Catalog Number :

Device Description : Drape Flex

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

ThermoFlo® - 00810050853880 Catalog Number :

Device Description : ThermoFlo Neo

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050853897 Catalog Number :

Device Description : ThermoFlo Filter w/ Drape Flex

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

ThermoFlo® - 00810050853903 Catalog Number :

Device Description : ThermoFlo Heat Moisture Exchanger

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050853910 Catalog Number :

Device Description : CircuitGuard ThermoFlo Right Angle Filter with Mask 4

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050853927 Catalog Number :

Device Description : Poppel Flex

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050853934 Catalog Number :

Device Description : ThermoFlo 1 Filter with Elbow and #5 Mask

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050853941 Catalog Number :

Device Description : ThermoFlo 1 Filter with Elbow and #4 Mask

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050853958 Catalog Number :

Device Description : 72 Unlimb Circuit with 3L Bag

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

ARC Medical - 00810050854016 Catalog Number :

Device Description : 72 Circuit with 2L Bag Latex Free

Device Class : 1

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

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