Avance® Solo

Avance Solo Set with Dressing 10x20cm

Registry build 21.09.26
8manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OMP
Manufacturer City Province Registered as Device types
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Shanghai ISO Medical Products Co., Ltd. Shanghai Shanghai Contract manufacturer 8
Zhejiang Longterm Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 26
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
Devon Medical Products (Jiangsu) Ltd Nantong Jiangsu Repacker / relabeller 12
Nantong MedTech Medical Products Co., Ltd. Nantong Jiangsu Contract manufacturer 6
Lightstone Medical Products (Ningbo) Co Ltd Ningbo Zhejiang Specification developer 3

Record

Regulatory record for Avance® Solo
Listed by Mölnlycke Health Care AB
FDA product code OMP
Device type Negative Pressure Wound Therapy Powered Suction Pump
Device class Class 2
Regulation 21 CFR 878.4780
510(k) K203369
Record published 2022-01-31
Record revised 2024-12-16 (version 3)

Specifications

Specifications
MRI safety MR Safe
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment humidity 10 to 75 % RH; Storage environment temperature 5 to 30 °C
Packaging Pack of 2, case of 2, pack of 4

Catalogue Numbers

Catalogue numbers for Avance® Solo
Catalogue number Size Status
881020 In distribution
8881020 In distribution
8881035 Not Applicable In distribution
8881030 In distribution
882525 In distribution
8881035 In distribution
882000 In distribution
881030 In distribution
8880050 In distribution
880050 In distribution
881035 In distribution
881530 In distribution
881515 In distribution
8881020 Not Applicable In distribution
8881030 Not Applicable In distribution
882020 In distribution
881520 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 57
Pico Smith & Nephew, Inc. 57
Negative Pressure Wound Therapy Powered Suction Pump Carilex Medical, Inc. 43
DeRoyal Deroyal Industries, Inc. 34
extriCARE Oakwell Distribution, Inc. 32
Renasys Smith & Nephew, Inc. 27
MicroDoc Npwt System Pensar Medical 26
ExtriCARE Alleva Medical Ltd 22
Vcare Alpha I.V.T. Medical Ltd 19
V.A.C.® Granufoam™ KCI USA, Inc. 19
Avance Mölnlycke Health Care AB 18
Silverlon Antimicrobial Wound Dressing Argentum Medical, LLC 14

Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump

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