Amekina 419842
GUDID 00898021000372
Amekina Skin and Wound Spray
Angelini Pharma Inc.
Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution| Primary Device ID | 00898021000372 |
| NIH Device Record Key | 2c25d985-77db-458e-a75d-949b7b1d453c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amekina |
| Version Model Number | 200 ML Spray |
| Catalog Number | 419842 |
| Company DUNS | 078843940 |
| Company Name | Angelini Pharma Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 1-800-726-2308 |
| customerservice@angelini-us.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright in original container |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store less than 95 degree Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00898021000372 [Primary] |
| GS1 | 10898021000379 [Package] Package: Case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082858
FDA Product Code
| FQH | Lavage, Jet |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-15 |
| Device Publish Date | 2023-02-07 |
Devices Manufactured by Angelini Pharma Inc.
| 20898021000383 - Peracidin® | 2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant |
| 20898021000406 - Peracidin® | 2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant |
| 00898021000419 - Peracidin® | 2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant |
| 00898021000037 - Maky 21.1 | 2023-02-15 Dialyzer reprocessing machine. |
| 00898021000181 - Peracidin™ | 2023-02-15 PAA Dialyzer Disinfectant. |
| 00898021000228 - Peracidin™ | 2023-02-15 PAA Dialyzer Disinfectant. |
| 00898021000204 - Peracidin™ | 2023-02-15 PAA Dialyzer Disinfectant. |
| 00898021000235 - PeraSidual | 2023-02-15 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis |
Trademark Results [Amekina]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMEKINA 98312830 not registered Live/Pending |
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.p.A. 2023-12-13 |
 AMEKINA 98312774 not registered Live/Pending |
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.p.A. 2023-12-13 |
 AMEKINA 90185391 not registered Live/Pending |
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.p.A. 2020-09-16 |
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