FDA.reportPublic FDA data

Peracidin®

Primary DI
00898021000389
Brand
Peracidin®
Company
Angelini Pharma Inc.
Model
Gallon
Catalog number
081894
Device description
Dialyzer Reprocessing Concentrate and RO Disinfectant
Published
2024-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEDSterilant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962959000PERACIDIN DIALYZER REPROCESSING CONCENTRATEHdc Medical, Inc.1998-06-05MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20898021000383PackageGS14In Commercial Distribution
00898021000389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089802100038320898021000383
00898021000389008980210003898980210003890898021000389

GMDN Terms#

Term, Definition table
TermDefinition
Organic peroxy acid device sterilant, single-useA substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Explosive pressure rupture of the container can occur if not properly vented.
Special Storage Condition, Specify00Keep away from flames and high temperatures. Avoid light and heat and keep in a closed but vented container to prevent evaporation (concentration) and contamination.
Special Storage Condition, Specify00Stable under normal storage and handling conditions. Unstable when exposed to heat and contaminants.
Special Storage Condition, Specify00Strong oxidizers, reacts violently with many other materials, particularly flammable and combustible organic materials.

Contacts#

Phone, Email table
PhoneEmail
1-800-726-2308CustomerService@Angelini-US.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00898021000372Amekina 200 ML Spray419842 2023-02-07

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