Label: ACESO AG SILVER SILICONE FOAM WOUND DRESSING-
- NHRIC Code(s): 72678-003-01
- Packager: NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated August 21, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Indications
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DESCRIPTION
ACESO Ag, is an absorbent Silicone Silver Foam Dressing used for the management of exudative wounds. It provides a physiologically favorable moist wound environment for wound healing. ACESO Ag absorbs excess wound exudate. ACESO Ag uses silver as a preservative to control bacterial growth within the foam dressing.
ACESO Ag, Silicone Silver Foam Dressing provides a physiologically favorable environment that encourages wound healing and conforms to the wound site. It is easy to use, biocompatible and biodegradable. ACESO Ag, supports natural autolysis by rehydrating and softening necrotic tissue and eschar thereby encouraging autolytic debridement. The silver preservative in the dressing controls microbial growth for up to 7 days within the dressing, as demonstrated in vitro.
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Product Administration
1. Clean the wound with sterile water or normal saline and dry the surrounding skin gently.
2. Remove the release films to cover the wound according to the wound area. The dressing should overlap
the dry surrounding skin by at least 1-2 cm.
3. The frequency of replacing depends on patient's conditions and the exudates situation, such as every 24 hours or longer, but cannot exceed more than 7 days.
Note: Dressing may be moistened with sterile water or normal saline to ease removal. -
Warnings
1. ACESO Silicone Ag Foam Dressing is a single use. Do not reuse.
2. ACESO Silicone Ag Foam Dressing is sterile. Do not use it if the pouch is damaged or opened prior to use.
3. Do not suggest using this product on dry wounds.
4. Do not use ACESO Silicone Ag Foam Dressing together with oxidant, such as hypochlorite solutions or hydrogen peroxide.
5. ACESO Silicone Ag Foam Dressing may cause transient discoloration of the wound bed and surrounding skin. Frequent or prolonged use
of this product may result in permanent discoloration of skin.
6. ACESO Silicone Ag Foam Dressing does not replace the need for systemic therapy or other adequate infection treatment in the event of
clinical infection.
7. Do not use ACESO Silicone Ag Foam Dressing during radiation treatment or examinations, such as X-ray, magnetic resonance imaging
[MRI] ultrasound or diathermy.
8. Avoid contact with electrodes or conductive gels during electronic measurements, such as electrocardiograms [ECG], and
electroencephalograms [EEG].
9. ACESO Silicone Ag Foam Dressing is only used for external use. - CONTRAINDICATIONS
- PRECAUTIONS
- How Supplied
- Storage and Disposal
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACESO AG SILVER SILICONE FOAM WOUND DRESSING
dressing, wound, drugProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:72678-003 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:72678-003-01 4 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K170077 07/15/2019 Labeler - NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY (967054623)