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

Applicator, Absorbent Tipped, Sterile (KXG) (6) Filter, Bacterial, Breathing-Circuit (CAH) (2) Container, Specimen Mailer And Storage, Non-Sterile (NNK) (1) Percutaneous Sheath Introducer Kit (OFL) (1)

Premarket Exempt

No Yes

Clear

Specimen Collection Swab - 00810049689988 Catalog Number : SW0101

Device Description : Specimen Collection Swab - Nasopharyngeal

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Specimen Collection Swab - 00810050851848 Catalog Number : SW0201

Device Description : Specimen Collection Swab - Oropharyngeal

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Specimen Collection Swab - 00810050851909 Catalog Number : SW0102

Device Description : Specimen Collection Swab - Nasopharyngeal

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Specimen Collection Swab - 00810050851923 Catalog Number : SW0202

Device Description : Specimen Collection Swab - Oropharyngeal

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Typenex Introducer Set - 00810050851954 Catalog Number :

Device Description : 7 Fr x 12 cm HV MICRO INTRODUCER, Micro Access Tip .018 Ni GW, NON-MARKED, echo needle

Device Class : 2

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Specimen Collection Swab - 00810050852128 Catalog Number : SW0103

Device Description : Specimen Collection Swab - Nasopharyngeal

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Specimen Collection Swab - 00810050852159 Catalog Number : SW0203

Device Description : Specimen Collection Swab - Oropharyngeal

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

ThermoFlo® - 00810050852203 Catalog Number :

Device Description : ThermoFlo® Filter – Combined Heat Moisture Exchanger / Bacterial Viral Filter

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

circuitGuard® ThermoFlo® - 00810050852210 Catalog Number :

Device Description : circuitGuard® ThermoFlo® 1 Filter – Combined Heat Moisture Exchanger, Bacterial circuitGuard® ThermoFlo® 1 Filter – Combined Heat Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Typenex Transport Tubes - 00810050852319 Catalog Number : TC0101XNS

Device Description : Non Sterile Transport Tube - 5 ML - Caps Separate

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

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