What is the warranty period for the product?

We provide a half-year quality guarantee for fixing or changing the oxygen inhalator if it fails to function properly under correct usage and storage conditions.

What are the payment terms?

We accept T/T, LC, D/P, PayPal, Western Union, and Small-amount payment.

Medical Oxygen Regulator with FDA Certificate

Name: Medical Oxygen Regulator with FDA Certificate
Brand: DONGYAN INTERNATIONAL CO., LTD.
SKU: 872984445

Jiangsu, ChinaDONGYAN INTERNATIONAL CO., LTD.

US$8.00-13.00

1,000 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Customized

Certification

CE, FDA, ISO13485

Model NO.

DY-1-1

Scale

Medium

Type

Breathing Apparatus

Input Pressure

150bar

Safety Valve

3.5bar±0.5bar

Connecting Thread

Female G5/8

Gas Type

Oxygen

Output Pressure

2bar-3bar

Flowmeter Range

1L/Min-10L/15L/Min

Function

Oxygen Supply

LCD Display

Transport Package

Color Box

Specification

Ce ISO13485

Trademark

OEM

Origin

Jiangsu China

HS Code

9019200000

Production Capacity

20000/Month

Key features

FDA & CE Certified: Complies with FDA, CE, ISO13485, and Class II medical device standards for safety.

Customizable Colors: Available in green, blue, and yellow alternative colors to suit specific needs.

Durable Construction: Features an aluminum body with a brass core and sintered bronze inlet filter.

High Pressure Safety: Supports 3000psi maximum inlet pressure with an internal relief valve.

Precise Flow Control: Offers multiple flow settings (0-4, 0-8, 0-15, 0-25 L/min) with 12 settings each.

Easy to Read Gauge: Equipped with a 1-1/2'' diameter UL-listed gauge and easy-to-read flow rate window.

Versatile Connectivity: Compatible with various gas bottle connections including CGA540, CGA870, and CGA910.

Stable Performance: Piston design ensures comfortable and stable flow control for oxygen therapy.

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceYears of Export ExperienceExhibition Experience

DONGYAN INTERNATIONAL CO., LTD.

Jiangsu, China

CertifiedBusiness Type: Trading Company CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 14 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤8.11h CertifiedTerms of Payment: T/T, LC, D/P, etc.

AI-Powered supplier vetting

SummaryThe supplier is a small trading company in Wuxi, China, focused on hardware tools and related product sales. It has five employees, one R&D engineer, no cooperative suppliers reported, and no stated manufacturing capability. Customization is offered across samples, designs, full and minor customization, and the company reported new products during the past year, but it does not provide ODM services or OEM services for popular brands and has no available SDK. Service procedures, complaint handling, and corrective/preventive-action procedures are documented with follow-up records, although the approved-supplier list lacks approval signatures or dates. An audit by TUV Rheinland is reported as valid from June 30, 2026 to June 29, 2027, but the evaluation result is recorded as 0 without interpretation. Quality-assurance and traceability status are unknown, and no quality-control test equipment is reported. Financial records are indicated for 2023–2025, but no financial performance conclusion is possible from...

Supplier typeThe supplier is explicitly identified as a trading company and limited company located in Wuxi, China, with five employees and no reported affiliation with a larger group. Its stated activities center on sales and wholesale of hardware tools, machinery, hardware and electrical appliances, construction materials, and related goods, indicating a small independent trading profile rather than a manufacturing entity.

After-Sales capabilityThe supplier has a documented service-capability assessment procedure with follow-up records, a corrective and preventive action procedure with records, and a clear customer-complaint procedure with follow-up records. However, the approved-supplier list lacks approval signatures or dates; this does not directly negate complaint or service handling, but it indicates an administrative control weakness.

R&D capabilityThe supplier reports at least one new product during the past year and has one R&D engineer, supporting some product-development activity. Nevertheless, it has no available SDK, does not provide ODM services, and the limited staffing indicates only modest documented R&D capacity rather than a strong innovation platform.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full customization, minor customization, and flexible customization. It also reports new products during the past year, although no ODM service, SDK, or detailed engineering resources beyond one R&D engineer are available.