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) (6) Mask, Oxygen, Non-Rebreathing (KGB) (4)

Premarket Exempt

Yes No

Clear

7450 RV2 MASK - 00817136021621 Catalog Number : 113700

Device Description : 7450L W/2600 MED 2W NRBV & HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021638 Catalog Number : 113701

Device Description : 7450M W/2600 MED 2W NRBV & HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021645 Catalog Number : 113702

Device Description : 7450S W/2600 MED 2W NRBV & HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5530 3L SYRINGE - 00817136021652 Catalog Number : 113707

Device Description : 5530 HRI 3L CAL SYR W/NDD OUTL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021669 Catalog Number : 113709

Device Description : 5570 3L CAL SYR NSPIRE

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021676 Catalog Number : 113711

Device Description : 5570 3L CALSYR CUSTOM 2X PORTS

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021683 Catalog Number : 113712

Device Description : 5570 3L 29.8MMID TPR INTG OUTL

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5550 .5L SYRINGE - 00817136021690 Catalog Number : 113713

Device Description : 5550 .5L CAL SYR W/30mm OUTLT

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021706 Catalog Number : 113740

Device Description : 5570 3L CAL SYRINGE QRS OUTLET

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7930 MASK - 00817136021713 Catalog Number : 113742

Device Description : 7930-40 MED/SM M/F MASK w/2730

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

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