FDA.reportPublic FDA data

Amekina

Primary DI
00898021000372
Brand
Amekina
Company
Angelini Pharma Inc.
Model
200 ML Spray
Catalog number
419842
Device description
Amekina Skin and Wound Spray
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082858000EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSERAlcavis International, Inc.2009-05-27FQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898021000379PackageGS124In Commercial Distribution
00898021000372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089802100037910898021000379
00898021000372008980210003728980210003720898021000372

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight
Special Storage Condition, Specify00Store less than 95 degree Fahrenheit
Special Storage Condition, Specify00Store upright in original container

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-726-2308customerservice@angelini-us.com

Regulatory Flags#

DUNS number
078843940
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898021000389Peracidin®Gallon0818942024-03-22
00898021000402Peracidin®Quarts0818982024-03-22
20898021000383Peracidin®Gallon0818942024-03-22
20898021000406Peracidin®Quarts0818982024-03-22
00898021000419Peracidin®Drum0818962024-03-22
00898021000051Alcavis 50500 mL155012016-08-29
00898021000044Alcavis 50250 mL155082016-08-29
00898021000068Alcavis 50200 mL Spray155022016-08-29
00898021000075ExSept Plus500 mL151172016-08-29
00898021000105ExSept Plus100 mL151042016-08-29
00898021000198Peracidin™Gallon1632-042016-08-29
00898021000297Peracidin RO DisinfectantQuarts1633Q2017-08-04
00898021000037Maky 21.121.1MAKY21.12016-08-29
00898021000181Peracidin™Quarts1632-122016-08-29
00898021000228Peracidin™Gallon1632-042016-08-29
00898021000204Peracidin™Drum1632-552016-08-29
00898021000235PeraSidual1702-011702-012017-05-23
00898021000242PeraChek1701-011701-012017-05-23
00898021000310Peracidin RO DisinfectantQuarts1633Q2017-08-04
00898021000303Peracidin RO DisinfectantGallon1633G2017-08-04

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07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
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03600040970676ElefantColoplast A/SFQH2024-04-05
03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
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00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10