AC611

Medium, AC611 High Flow Nasal Cannula, Filtered Exhalation Port Connection, Japan

Registry build 21.09.26
97manufacturers in China registered for this device type
19catalogue 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 AC611
Listed by Respironics 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, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-04-25
Record revised 2022-03-22 (version 3)

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
Storage Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F
Packaging Multipack of 20, multipack of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for AC611
Catalogue number Size Status
AC611 High Flow Nasal Cannula, FEP Connect, Small, INTL In distribution
AC611 High Flow Nasal Cannula, FEP Connect, Medium, INTL In distribution
AC611 High Flow Nasal Cannula, 22mm (M), Large, NA In distribution
00 In distribution
AC611 High Flow Nasal Cannula, 22 mm (M), Small, INTL In distribution
00 In distribution
AC611 High Flow Nasal Cannula, FEP Connect, Large, INTL In distribution
00 In distribution
00 In distribution
AC611 High Flow Nasal Cannula, 22mm (M), Medium, INTL In distribution
AC611 HFNC, FEP Connect Demo Kit, INTL In distribution
AC611 High Flow Nasal Cannula, FEP Connect, Large, NA In distribution
AC611 High Flow Nasal Cannula, 22 mm (M), Small, US In distribution
AC611 High Flow Nasal Cannula, 22mm (M), Large, INTL In distribution
AC611 High Flow Nasal Cannula, FEP Connect, Medium, US In distribution
00 In distribution
AC611 High Flow Nasal Cannula, 22mm (M), Medium, NA In distribution
AC611 HFNC, Filtered Exhalation Port Connect Demo Kit In distribution
AC611 High Flow Nasal Cannula, FEP Connect, Small, US 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
Vapotherm Vapotherm Inc. 41
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

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