Amekina 419842
GUDID 00898021000372
Amekina Skin and Wound Spray
Angelini Pharma Inc.
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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