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) (5) Mask, Oxygen, Non-Rebreathing (KGB) (5)

Premarket Exempt

Yes No

Clear

5570 3L SYRINGE - 00817136021522 Catalog Number : 113659

Device Description : 5570 3L CAL SYR COSMED

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021539 Catalog Number : 113660

Device Description : 5570 3L 1.125OD/22 GREY HRI

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021546 Catalog Number : 113661

Device Description : 7450M W/MOD 2730 LG 2W Y NRBV

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021553 Catalog Number : 113662

Device Description : 7450S W/MOD 2730 LG 2W Y NRBV

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021560 Catalog Number : 113676

Device Description : 5570 SYRINGE 3L OEM ERT

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021577 Catalog Number : 113679

Device Description : 5570 3L SYR PER SIBEL MED

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7450 RV2 MASK - 00817136021584 Catalog Number : 113694

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 - 00817136021591 Catalog Number : 113695

Device Description : 7450 V2 SMALL 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 - 00817136021607 Catalog Number : 113696

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

5570 3L SYRINGE - 00817136021614 Catalog Number : 113699

Device Description : 5570 QRS 3L SYRINGE

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

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