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) (9) Mask, Oxygen, Non-Rebreathing (KGB) (1)

Premarket Exempt

No Yes

Clear

5570 3L SYRINGE - 00817136021126 Catalog Number : 113414

Device Description : 5570 3L CAL SYRINGE PER NDD

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021133 Catalog Number : 113416

Device Description : 5570 3L CAL SYRINGE PER QRS

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021140 Catalog Number : 113418

Device Description : 5570 3L SYR HRI TOURQ NPB OUTL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021157 Catalog Number : 113419

Device Description : 5570 3LSYR HRITOURQ KOKO FILTR

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021164 Catalog Number : 113420

Device Description : 5570 3L SYRINGE DIAGNOSTICA

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5530 3L SYRINGE - 00817136021171 Catalog Number : 113422

Device Description : 5530 3L CAL SYR W/1.375OD OUTL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021188 Catalog Number : 113464

Device Description : 5570 3L SYR-TOURQ, 612735 OUTL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7400 RV2 MASK - 00817136021195 Catalog Number : 113476

Device Description : 7400M 2730 LG 2W NRBV 220D EXH

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021201 Catalog Number : 113477

Device Description : 5570 3L SYR ALLIANCE TECH

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021218 Catalog Number : 113568

Device Description : 5570 3L SYR 28/22MM OUTLET

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

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