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HANS RUDOLPH, INC.

United States·US-MF-000004498

Last updated September 17, 2026

Information

Country: United States
Address: 8325, Cole Parkway, Shawnee, United States
Website: www.rudolphkc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1 913 422 7788
PRRC Contact: Brian Chipman
EUDAMED SRN: US-MF-000004498
FDA FEI Number: 1922553
DUNS Number: —

Catalogue (1166)

Page 16 of 24

Device	Model / Reference	Registries	Class	Status
Volume Calibration Syringe	113612	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	113595	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	113609	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	CR1852	EUDAMEDFDA UDI	Class I	Active
series callibration syringes	CR1742	EUDAMEDFDA UDI	Class I	Active
Volume Calibration Syringe	CR2007	EUDAMEDFDA UDI	Class I	Active
oro-nasal mask	113517	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	113599	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	113926	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	113524	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	113881	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	115216	EUDAMEDFDA UDI	Class IIa	Active
Series Oro-Nasal Mask	201547	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	115020	EUDAMEDFDA UDI	Class IIa	Active
4200 Pneumatic Mouth Shutter	K791705	FDA 510(k)	Class II	Active
Mask, Gas, Anesthetic	K945894	FDA 510(k)	Class I	Active
7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit	K020759	FDA 510(k)	Class II	Active
Hans Rudolph Nasal Cpap Mask	K962848	FDA 510(k)	Class I	Active
Directional Control Valves Inflatable Balloon-Type And Controllers	K946077	FDA 510(k)	Class II	Active
Ultimate Seal	K960401	FDA 510(k)	Class I	Active
Nonrebreathing Valve	K933583	FDA 510(k)	Class I	Active
7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/Nppv Masks	K030822	FDA 510(k)	Class II	Active
Hri 6500, 6600 And 6700 Series V2masks	K071149	FDA 510(k)	Class II	Active
Non Conductive Anesthesia Face Mask, Silicone	K932147	FDA 510(k)	Class I	Active
Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks	K030515	FDA 510(k)	Class II	Active
Series Oro-Nasal Masks	CC1758	EUDAMEDFDA UDI	Class IIa	Active
Series oro-nasal masks	201672	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	115108	EUDAMEDFDA UDI	Class IIa	Active
series callibration syringes	113811	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	115006	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	112801	EUDAMEDFDA UDI	Class I	Active
Series Oro-Nasal Mask	113529	EUDAMEDFDA UDI	Class IIa	Active
Series Oro-Nasal Masks	201608	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	CR2047	EUDAMEDFDA UDI	Class I	Active
Series Oro-Nasal Masks	CC1895	EUDAMEDFDA UDI	Class IIa	Active
series callibration syringes	112710	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	669153	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	113713	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	113899	EUDAMEDFDA UDI	Class IIa	Active
Series Oro-Nasal Masks	CC1859	EUDAMEDFDA UDI	Class IIa	Active
Series Oro-Nasal Masks	201610	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	115015	EUDAMEDFDA UDI	Class IIa	Active
Series Oro-Nasal Masks	CC1748	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	113532	EUDAMEDFDA UDI	Class IIa	Active
Series Oro-Nasal Masks	CC1734	EUDAMEDFDA UDI	Class IIa	Active
Volume Calibration Syringe	CR1715	EUDAMEDFDA UDI	Class I	Active
Volume Calibration Syringe	113919	EUDAMEDFDA UDI	Class I	Active
Oro-Nasal Mask	115005	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	113513	EUDAMEDFDA UDI	Class IIa	Active
Oro-Nasal Mask	113500	EUDAMEDFDA UDI	Class IIa	Active

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