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

Mask, Oxygen, Non-Rebreathing (KGB) (8) Calibrator, Volume, Gas (BXW) (1) Tubing, Pressure And Accessories (BYX) (1)

Premarket Exempt

No Yes

Clear

4285 SLIDE VLV CONTROL - 00817136020402 Catalog Number : 112960

Device Description : 4285BF 2 SLIDE VLV CNTRL 230V

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

7950 MASK - 00817136020419 Catalog Number : 112961

Device Description : 7950 PED LG M/F MASK W/2630 2W

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7950 MASK - 00817136020426 Catalog Number : 112962

Device Description : 7950 PED LG M/F MASK W/2600 2W

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7950 MASK - 00817136020433 Catalog Number : 112963

Device Description : 7950 PED LG M/F MASK W/1420A

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7950 MASK - 00817136020440 Catalog Number : 112964

Device Description : 7950 PED LG M/F MASK W/1410A

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7950 MASK - 00817136020457 Catalog Number : 112965

Device Description : 7950 PED LG M/F MASK W/1420B

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7950 MASK - 00817136020464 Catalog Number : 112966

Device Description : 7950 PED LG M/F MASK W/1410B

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5530 3L SYRINGE - 00817136020471 Catalog Number : 112973

Device Description : 5530 3L CAL SYR 1.375ID ORING"

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

8920 MASK - 00817136020488 Catalog Number : 113012

Device Description : 8920 ADULT LG MASK W/2730 2W

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

8930 MASK - 00817136020495 Catalog Number : 113013

Device Description : 8930 ADULT MED MASK W/2730 2W

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

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