ACE

Suction Tubing Adapter SET *steam Sterilize Only* Tubing IS Amber Latex

Registry build 21.09.26
23manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Jiangsu (8), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EBR
Manufacturer City Province Registered as Device types
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Shanghai Greeloy Industry Co., Ltd. Shanghai Shanghai Contract manufacturer 9
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai Shanghai Contract manufacturer 32
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31

Showing 12 of 23. All 23 manufacturers in China registered for Unit, Suction Operatory

Record

Regulatory record for ACE
Listed by Ace Surgical Supply Co., Inc., United States
FDA product code EBR
Device type Unit, Suction Operatory
Device class Class 1
Regulation 21 CFR 872.6640
Premarket notification Exempt
Record published 2019-10-16
Record revised 2021-06-08 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Storage Special storage condition: No special storage conditions required
Sizes Length 1 to 10 ft
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ACE
Catalogue number Size Status
0032962 In distribution
0034245 Length 10 ft In distribution
0034239 Length 6 ft In distribution
0032959 In distribution
0032951 In distribution
0034244 Length 6 ft In distribution
0032942 In distribution
0030276 Length 1 ft In distribution
0032966 In distribution
0034241 Length 6 ft In distribution
0032955 In distribution
0032952 In distribution
0034238 Length 3 ft In distribution
0032940 In distribution
0034235 Length 3 ft In distribution
0032943 In distribution
0032965 In distribution
0034242 Length 10 ft In distribution
0900210 In distribution
0032958 In distribution
0032963 In distribution
0034237 Length 10 ft In distribution
0034236 Length 6 ft In distribution
0032950 In distribution
0032944 In distribution
0034237B Length 10 ft In distribution
0032953 In distribution
0032960 In distribution
0032964 In distribution
0034240 Length 10 ft In distribution
0032954 In distribution
0032948 In distribution
0032961 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Isolite, i3 Zyris, Inc. 24
A-dec A-dec, Inc. 12
Isovac, Connector Zyris, Inc. 9
Aesculap Aesculap AG 8
Isodry Zyris, Inc. 7
Hygitech Hygitech 7
Isovac Zyris, Inc. 6
Kohdent Kohler Medizintechnik GmbH 5
Isolite, i2 Zyris, Inc. 3
Maquira Maquira Industria de Produtos Odontologicos S/A 3
Accessories Zyris, Inc. 3
Nordent Manufacturing Inc Nordent Manufacturing Inc 2

Showing 12 of 37. All products under Unit, Suction Operatory

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