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

Calibrator, Volume, Gas (BXW) (8) Clip, Nose (BXJ) (1) Mask, Oxygen, Non-Rebreathing (KGB) (1)

Premarket Exempt

Yes No

Clear

5570 3L SYRINGE - 00817136021829 Catalog Number : 113763

Device Description : 5570 OMI 3L CAL SYR NDD OUTLET

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

4900 7L SYRINGE - 00817136021836 Catalog Number : 113764

Device Description : 7L MASTER SYRINGE 6 NIST CALS

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021843 Catalog Number : 113802

Device Description : 7450M W/HG & 2700 2W LESS SMPL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021850 Catalog Number : 113806

Device Description : 5570 3L SYR HRI TOURQ CUST ADP

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5530 3L SYRINGE - 00817136021867 Catalog Number : 113811

Device Description : 5530 3LSYR HRI TAN KOKO FILTR

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021874 Catalog Number : 113817

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

5570 3L SYRINGE - 00817136021881 Catalog Number : 113832

Device Description : 5570 3L SYR HRI VITALOGRAF-OUT

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

9015 REUSABLE NOSECLIPS - 00817136021898 Catalog Number : 113835

Device Description : NOSE CLIP PER AVON PROTECTION

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXJ

Prescription Use : Yes

Device Count : 1

5540 1L SYRINGE - 00817136021904 Catalog Number : 113840

Device Description : 5540 1L SYR 15mm ID OUTLET

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021911 Catalog Number : 113841

Device Description : 5570 3L HRI SYR SIBEL OUTLET

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

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