Who else makes this device?

Name: Responsive Respiratory, Inc.
Brand: Responsive Respiratory, Inc.

Responsive Respiratory, Inc. · Regulator, Pressure, Gas Cylinder → Anesthesiology

27manufacturers in China registered for this device type

24catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (14), Guangdong (4), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAN
Manufacturer	City	Province	Registered as	Device types
Dragon Medical Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	48
Jiangsu Saikang Medical Equipment Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	34
Cofoe Medical Technology Co., Ltd.	Changsha	Hunan	Contract manufacturer	22
Jiangsu Yuyue Medical Equipment & Supply Company Limited	Jiangsu	Jiangsu	Contract manufacturer	17
Foshan City Nanhai Chiahui Hardware&Plastic Product Co Ltd	Danzao, Foshan	Guangdong	Contract manufacturer	1
Ninghai Dingli Water-Heating Equipment Plant	Ningbo	Zhejiang	Contract manufacturer	1
Saferlife Products Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	58
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	Danyang	Jiangsu	Contract manufacturer	37
Rusun Medical Co., Ltd.	Yichun	Jiangxi	Manufacturer	37
A & I Industries Ltd	Foshan	Guangdong	Manufacturer	35
Emsrun Group	Wuxi	Jiangsu	Specification developer	34
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33

Showing 12 of 27. All 27 manufacturers in China registered for Regulator, Pressure, Gas Cylinder

Record

Regulatory record for Responsive Respiratory, Inc.
Listed by	Responsive Respiratory Inc., United States
FDA product code	CAN
Device type	Regulator, Pressure, Gas Cylinder
Device class	Class 1
Regulation	21 CFR 868.2700
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2023-06-09
Record revised	2024-02-05 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Over the counter	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Responsive Respiratory, Inc.
Catalogue number	Size	Status
120-1010C		In distribution
120-3010		In distribution
120-1010NG		In distribution
120-1205		In distribution
120-1031C		In distribution
120-1230		In distribution
120-3030		In distribution
120-1061C		In distribution
120-3040		In distribution
120-3031		In distribution
120-1000C		In distribution
200-0120		In distribution
120-1040C		In distribution
120-2050		In distribution
120-1210		In distribution
200-0122		In distribution
120-1070C		In distribution
120-1200		In distribution
120-1060C		In distribution
120-1260		In distribution
120-3061		In distribution
120-1030C		In distribution
120-3060		In distribution
120-1220		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ohio	Ohio Medical LLC	261
Western/Scott Fetzer	Western Enterprises, Inc.	178
Mada Medical Products, Inc.	Mada Medical Products, Inc.	78
Sinya	Danyang Xinya Valve Co., Ltd.	47
Control Devices	Control Devices, LLC	41
Regulator, Pressure, Gas Cylinder	Control Devices, LLC	38
The Harris Products Group	J. W. Harris Co., Inc.	37
PC	Allied Medical LLC	35
BF	Allied Medical LLC	34
MediSelect II	GCE, s.r.o.	28
Varimed+	GCE, s.r.o.	28
EM	Allied Medical LLC	27

Showing 12 of 155. All products under Regulator, Pressure, Gas Cylinder

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K061785	2006-09-07

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Responsive Respiratory, Inc.