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

No Yes

Clear

5570 3L SYRINGE - 00817136021225 Catalog Number : 113611

Device Description : 5570 3L SYR HRI TOURQ 22/15mm

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021232 Catalog Number : 113612

Device Description : 5570 3L SYR HRI TOURQ 35mmOD

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021249 Catalog Number : 113615

Device Description : 5570 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

7400 RV2 MASK - 00817136021256 Catalog Number : 113617

Device Description : 7400 L W/2700 WITH HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7400 RV2 MASK - 00817136021263 Catalog Number : 113618

Device Description : 7400 M W/2700 WITH HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

7400 RV2 MASK - 00817136021270 Catalog Number : 113619

Device Description : 7400 S W/2700 WITH HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

4900 7L SYRINGE - 00817136021287 Catalog Number : 113622

Device Description : 4900 7L SYR 1.375 ID O-RNG"

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021294 Catalog Number : 113625

Device Description : 5570 3L CAL SYR PER MIDMARK

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

7400 RV2 MASK - 00817136021300 Catalog Number : 113629

Device Description : 7400 ES W/2700 LG 2W WITH HG

Device Class : 1

Duns Number: 007131725

Premarket Exempt : No

Product Code : KGB

Prescription Use : Yes

Device Count : 1

5570 3L SYRINGE - 00817136021317 Catalog Number : 113630

Device Description : 5570 3L SYR 32mm/38mm OUTLET

Device Class : 1

Duns Number: 007131725

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

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