Agile
AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell that provides moisture management and gelling fiber properties. AGILE is indicated for the…
AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell that provides moisture management and gelling fiber properties. AGILE is indicated for the management of acute and chronic wounds: partial-thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, tunneling, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). AGILE consists of a white polyester/ lyocell wound contact layer and two blue polyester/ lyocell waffle knit fabrics laminated together. The blue side of the dressing is placed away from the wound.
Who Else Makes It
Concentrated in Zhejiang (55), Jiangsu (42), Guangdong (32). 33 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
Showing 12 of 195. All 195 manufacturers in China registered for Dressing, Wound, Hydrophilic
Record
| Listed by | Milliken Healthcare Pdts, LLC |
|---|---|
| FDA product code | NAC |
| Device type | Dressing, Wound, Hydrophilic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4018 |
| Premarket notification | Exempt |
| Record published | 2021-02-04 |
| Record revised | 2021-07-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 131 °F |
| Packaging | Shelf box of 10, shipper box of 5, shipper case of 5, shelf box of 2, shipper of 5 |
| Sizes | Area/surface area 4 to 40 Square inch |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4″x4″ | Area/Surface Area 16 Square inch | In distribution |
| Pre-cut 4″x4″ | Area/Surface Area 16 Square inch | In distribution |
| 2″x2″ | Area/Surface Area 4 Square inch | In distribution |
| 4″x10″ | Area/Surface Area 40 Square inch | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 170 |
| Simpurity | Safe N Simple LLC | 91 |
| AMD-Ritmed ALL Gauze | AMD Medicom Inc. | 80 |
| 3M™ Tegaderm™ | 3M Company | 78 |
| Cutimed® Sorbion® | BSN Medical, Inc. | 70 |
| AMD-Ritmed | AMD Medicom Inc. | 63 |
| Medline | Medline Industries, Inc. | 56 |
| Dododots | Dodo Ventures SDN. BHD | 42 |
| Aquacel Foam | Convatec, Purchasing Department | 39 |
| McKesson | Mckesson Medical-Surgical Inc. | 37 |
| Vitale | CellEra, LLC | 36 |
| MedVance | MED WAY Inc. | 36 |
Showing 12 of 432. All products under Dressing, Wound, Hydrophilic
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.