Intelair Nasal Airway Support System

Airway Assembly, 13cm, Pouched

Registry build 21.09.26
29manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (17), Jiangsu (5), Zhejiang (3). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CCK
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13
Ningbo Xinwell Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 12
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11

Showing 12 of 29. All 29 manufacturers in China registered for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Record

Regulatory record for Intelair Nasal Airway Support System
Listed by Applied Medical Technology, Inc., United States
FDA product code CCK
Device type Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class Class 2
Regulation 21 CFR 868.1400
Establishment Manufacturer, Exporter
Record published 2023-07-01
Record revised 2024-05-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Box 1 (nr212613-1), box 3 (nr212613-3) of 3, box 1 (nr212611-1), box 3 (nr212611-3) of 3, box 1 (nr212612-1), box 3 (nr212612-3) of 3
Sizes Length 11 to 14 cm
Distribution end date 2023-07-01

Catalogue Numbers

Catalogue numbers for Intelair Nasal Airway Support System
Catalogue number Size Status
ENR212613 Length 13 cm Withdrawn
ENR212611 Length 11 cm Withdrawn
ENR212612 Length 12 cm Withdrawn
ENR212614 Length 14 cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Salter Labs 241
Microstream Oridion Medical 1987 Ltd. 92
Hudson RCI Teleflex Medical LLC 79
Medline Medline Industries, Inc. 65
BCI ICU Medical, Inc 64
Curaplex Bound Tree Medical, LLC 60
Microstream Advance Oridion Medical 1987 Ltd. 51
Ventlab Ventlab, LLC 42
Vital Signs Carefusion Finland 320 Oy 33
AirLife™ Airlife, Inc. 32
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Nihon Kohden Corp. 23
Curaplex TRI-Anim Health Services, Inc. 23

Showing 12 of 441. All products under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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