FDA UDI
In Commercial Distribution
🇺🇸 United States
Amekina
DI: 00898021000372
·
Model: 200 ML Spray
·
Angelini Pharma Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Amekina
- Primary DI
- 00898021000372
- Version / Model
- 200 ML Spray
- Catalog Number
- 419842
- Company Name
- Angelini Pharma Inc.
- Labeler DUNS
- 078843940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 1
- Public Version Date
- 2023-02-15
- Public Version Status
- New
- Public Device Record Key
- 2c25d985-77db-458e-a75d-949b7b1d453c
Device Description
Amekina Skin and Wound Spray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FQH | Lavage, Jet | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59523 | Antimicrobial wound irrigation solution | A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00898021000372 | GS1 | ||||
| Package | 10898021000379 | GS1 | Case | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-726-2308
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082858 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store upright in original container
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store less than 95 degree Fahrenheit