Anasept Antimicrobial Skin and Wound Gel
Basic Information
- Brand Name
- Anasept Antimicrobial Skin and Wound Gel
- Primary DI
- 00367180500035
- Version / Model
- 5003G
- Catalog Number
- 5003G
- Company Name
- ANACAPA TECHNOLOGIES, INC.
- Labeler DUNS
- 073189370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-06
- Public Version
- 2
- Public Version Date
- 2020-07-28
- Public Version Status
- Update
- Public Device Record Key
- 1033ad6a-3d15-4d47-aa90-240aea8b0043
Device Description
Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® Gel inhibits the growth of microorganisms, such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59522 | Wound hydrogel dressing, antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00367180512038 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00367180500035 | GS1 |
Customer Contacts
- Phone
- 909-394-7795
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073547 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 86 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature