Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063407

FEI Number

3001237796

Entity Name

The Ritedose Corporation

City/State/Country

Bendale, SC, US

Establishment Address

1 Technology Cir, and 1135 and 1150 Performance Parkway, Bendale, SC 29203, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

The Ritedose Corporation (Owner Number: 9030287)

Owner / Operator Contact Address

1 TECHNOLOGY CIRCLE, --, Columbia, SC 29203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sodium Chloride Inhalation Solution, USP Sodium Chloride Inhalation Solution, 7% Sodium Chloride Inhalation Solution, 3.5% Sodium Chloride Inhalation Solution, 10% Sodium Chloride Inhalation Solution, 3% Hyper Sal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-08-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-13
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-12-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-13
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-06-17

Official Correspondent

Cynthia Avants

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Ritedose Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

Registration Number	Establishment Name	Location
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063407. Last updated year: 2026. Please use registration number 1063407 when referencing this establishment in official correspondence.