Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007494890

FEI Number

3007494890

Entity Name

SUNRISE MEDICAL INTERNATIONAL INC.

City/State/Country

Carmel, IN, US

Establishment Address

2986 Jason St, Carmel, IN 46033, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Sunrise Medical International Inc. (Owner Number: 10028631)

Owner / Operator Contact Address

2986 Jason St, Carmel, IN 46033, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sure Seal Aluminum Washer (Neoprene Sure Seal Brass Washer (Viton) Sure Seal Brass Washer (Neoprene) Cylinder wrench Airway (Non-Center-Vented) Airway (Center-Vented) Swivel Oxigen Tubing Kinking Releas C-Pap Oxigen Intubation Adaptor Oxygen Connector 6 mm Y connector Oxygen Tubing End Connector Bird Adaptor Dual Trach Swivel Adap w/Suction Swivel Oxygen Connector CAPA Tubing Cuff Adapter Dual Trach Suction Adap w/o Suction Oxygen Inlet (Barb) (3/4") Oxygen Adaptor Aerosol Adaptor TRK Oxygen Bar 84" Oxygen Tubing Nose Clip (Design with Vented Pads)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAM	Yoke Assembly, Medical Gas	Anesthesiology	Class 1	868.6885	2009-02-19
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2009-02-19
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2009-02-19
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2009-02-19
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2009-02-19

Official Correspondent

Daihong Ren

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sunrise Medical International Inc.

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
K780365	Spica, Inc.	OXYGEN/NITROUS OXIDE OUTLET	1978-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Similar Registrations

Registration Number	Establishment Name	Location
1529989	Superior Products, LLC	Brooklyn, OH, US
2020813	ACCUTRON, INC.	PHOENIX, AZ, US
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3008341245	BAY CORPORATION	Westlake, OH, US
3003481016	SOLEETECH CORPORATION	Lujhou Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007494890. Last updated year: 2026. Please use registration number 3007494890 when referencing this establishment in official correspondence.