HANS RUDOLPH, INC.

Address:8325 COLE PKWY,Shawnee,KS,66227,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

Tubing, Pressure And Accessories (BYX) (5) Calibrator, Volume, Gas (BXW) (3) Bag, Reservoir (BTC) (1) Mask, Oxygen, Non-Rebreathing (KGB) (1)

Premarket Exempt

Yes No

Clear

5570 3L SYRINGE - 00817136021928 Catalog Number : 113842

Device Description : 5570 3L SYR HRI TOURQ NDD OUTL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

6000 NDGB - 00817136021935 Catalog Number : 113844

Device Description : 500 LITER NONDIFFUSING GAS BAG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BTC

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021942 Catalog Number : 113846

Device Description : 5570 3L SYR SIBEL INTEGRAL ADP

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

2870 3WAY SLIDE VALVE - 00817136021959 Catalog Number : 113847

Device Description : 2870/CLRA/2700 1.375 CP NO SMP

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021966 Catalog Number : 113849

Device Description : 7450S W/1410A SM 2W NRBV & HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021973 Catalog Number : 113850

Device Description : 3L SYR 5570 SERIES GERATHERM

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7000 CONNECTORS - 00817136021980 Catalog Number : 171013

Device Description : CONN 35OD X 22ID 7000 SERIES

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

7000 CONNECTORS - 00817136021997 Catalog Number : 171014

Device Description : CONN 35OD X 22OD 7000 SERIES

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

9300 - 00817136022000 Catalog Number : 171207

Device Description : FILTER/REG/GAGE LOWPRESS 25PSI

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : BYX

Prescription Use : Yes

Device Count : 1

7000 CONNECTORS - 00817136022017 Catalog Number : 171213

Device Description : CONN 50.8OD X 22ID 7000 SERIES

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

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