Assist Absorbent
ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Absorbent is indicated for management of acute and chronic wounds: partial thickness…
ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Absorbent is indicated for management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphedema, dermatological wounds, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer, two layers of absorptive non-woven, and a white occlusive outer layer.
Who Else Makes It
Concentrated in Jiangsu (9), Shandong (2), Zhejiang (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Ningbo First Import & Export Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 37 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
Showing 12 of 20. All 20 manufacturers in China registered for Sheet, Burn
Record
| Listed by | Milliken Healthcare Pdts, LLC |
|---|---|
| FDA product code | FPY |
| Device type | Sheet, Burn |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5180 |
| Premarket notification | Exempt |
| Record published | 2021-02-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 131 °F |
| Packaging | Shipper case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24″x36″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 19 |
| First Responder | Water-JEL Technologies, L.L.C. | 11 |
| Surgyco | Surgyco LLC | 4 |
| BurnFree | Water-JEL Technologies, L.L.C. | 3 |
| Medline | Medline Industries, Inc. | 2 |
| Military | Water-JEL Technologies, L.L.C. | 2 |
| MedSource Burn Sheet | Medsource International, LLC | 2 |
| Bandaging Cloth A 600mm x 800mm | Hans Hepp Gmbh & Co. KG | 2 |
| NAR | North American Rescue, LLC. | 1 |
| Sterile Burn Blanket | H & H Co. | 1 |
| EMP Burn Sheet | Medsource International, LLC | 1 |
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.