Vapotherm

Premature-Neonate-Infant Single Prong Nasal Cannula

Registry build 21.09.26
97manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (33), Guangdong (23), Jiangsu (17). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAT
Manufacturer City Province Registered as Device types
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Ningbo Mflab Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11

Showing 12 of 97. All 97 manufacturers in China registered for Cannula, Nasal, Oxygen

Record

Regulatory record for Vapotherm
Listed by Vapotherm Inc., United States
FDA product code CAT
Device type Cannula, Nasal, Oxygen
Device class Class 1
Regulation 21 CFR 868.5340
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-10-08
Record revised 2022-03-22 (version 5)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 25, case of 25, pack of 10, case of 10

Catalogue Numbers

Catalogue numbers for Vapotherm
Catalogue number Size Status
MP1500-BR In distribution
MPS1500-BR In distribution
ProSoft-Neo In distribution
MP1500-IN In distribution
QSOFT-MA1700 In distribution
SOLO1300-BR In distribution
MA1700-BR In distribution
MN1100A-BR In distribution
UNICORN-INF In distribution
SOLO1300-IN In distribution
MPS1500-IN In distribution
MA1700-IN In distribution
MI1300B-BR In distribution
QSOFT-MA1750 In distribution
MI1300-BR In distribution
MN1100B In distribution
MN1100A In distribution
SOLO1300 In distribution
ProSoft-Inf In distribution
MI1300B-IN In distribution
UNICORN-ADULT In distribution
MI1300-IN In distribution
MP1500 In distribution
MA1700-Soft In distribution
QSOFT-MP1500 In distribution
ProSoft-Ped-S In distribution
MI1300B In distribution
MPS1500-Soft In distribution
ProSoft-Adult In distribution
MP1500-Soft In distribution
ProSoft-XL In distribution
QSOFT-SOLO1700 In distribution
ProSoft-Pre In distribution
MA1700 In distribution
ProSoft-Ped-AS In distribution
MN1100A-IN In distribution
MI1300 In distribution
MPS1500 In distribution
ProSoft-Int-Inf In distribution
UNICORN-PED In distribution
MN1100B-IN In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cannula, Nasal, Oxygen Salter Labs 394
Hudson RCI Teleflex Medical LLC 92
AirLife™ Vyaire Medical, Inc. 61
Medline Medline Industries, Inc. 53
AirLife™ Airlife, Inc. 51
Hudson RCI Medline Industries, Inc. 44
Curaplex Bound Tree Medical, LLC 39
McKesson Mckesson Medical-Surgical Inc. 38
Curaplex TRI-Anim Health Services, Inc. 35
Create Biotech Create Biotech Co., Ltd. 34
ProCure Twin Med, LLC 32
Oxygen Kit Sunset Healthcare Solutions, Inc. 32

Showing 12 of 402. All products under Cannula, Nasal, Oxygen

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer