Sofnolime®

Sofnolime® 2550, W-V Indicating Disposable Cartridges Medline

Registry build 21.09.26
6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (4), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BSF
Manufacturer City Province Registered as Device types
GVS Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Shandong Jinlai Huanhai Medical Technology Co., Ltd. Yantai Shandong Manufacturer 19
Jiangsu Haize Medical Scientific Development Co., Ltd. Wuxi Jiangsu Manufacturer 9

Record

Regulatory record for Sofnolime®
Listed by Molecular Products Ltd, United Kingdom
FDA product code BSF
Device type Absorber, Carbon-Dioxide
Device class Class 1
Regulation 21 CFR 868.5310
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-09-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 0 to 35 °C
Packaging Box of 12

Catalogue Numbers

Catalogue numbers for Sofnolime®
Catalogue number Size Status
CD02-0055 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AincA® Anesthesia Associates, Inc. 3
Aria Molecular Products Ltd 3
Column, Ascarite, Desiccator, Disposable A-M Systems 3
Absorber, Carbon-Dioxide Datex-Ohmeda, Inc. 2
Column, Desiccator, Disposable, 7 In A-M Systems 2
Sodasorb® Molecular Products Ltd 1
Absorbent, C02, Sodalime A-M Systems 1
Abcan, Spherasorb™ Disposable CO2 Absorber, White TO Violet Colour Change, 1.1L Intersurgical Ltd. 1
Absorbent, CO2, Carbolime A-M Systems 1
Abcan, Loflosorb™ Disposable CO2 Absorber, Green TO Violet Colour Change, 1.1L Intersurgical Ltd. 1
Pyramid Mkii Loflosorb G/V Intersurgical Ltd. 1
Pyramid Mkii: Soda Lime Absorber Sherasorb W/V Intersurgical Ltd. 1

Showing 12 of 33. All products under Absorber, Carbon-Dioxide

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