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) (7) Calibrator, Volume, Gas (BXW) (3)

Premarket Exempt

Yes No

Clear

5510 100ML SYRINGE - 00817136021324 Catalog Number : 113636

Device Description : 5510 100ML CAL SYR 22/15MM

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021331 Catalog Number : 113637

Device Description : 5570 3L SMC/VIASYS FLOWMETER

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021348 Catalog Number : 113638

Device Description : 5570 3L SYR W/1.75OD TPR OUTLT

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021355 Catalog Number : 113639

Device Description : 7450 V2 LG W/HG & 2700 NRBV

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021362 Catalog Number : 113640

Device Description : 7450 V2 MED W/HG & 2700 NRBV

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021379 Catalog Number : 113641

Device Description : 7450 V2 SM W/HG & 2700 NRBV

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021386 Catalog Number : 113642

Device Description : 7450 V2 EXSM W/HG & 2700 NRBV

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021393 Catalog Number : 113643

Device Description : 7450 V2 PETITE W/HG & 2700 NRB

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021409 Catalog Number : 113644

Device Description : 7450 V2 LG W/HG & 2730 NRB

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021416 Catalog Number : 113645

Device Description : 7450 V2 MED W/HG & 2730 NRB

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

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