FDA.reportPublic FDA data

Pure&Clean

Primary DI
00852421007393
Brand
Pure&Clean
Company
Pure & Clean, LLC
Model
None
Catalog number
11WC16-ZRXI
Device description
Wound Solutions Rx Wound Irrigant Septa Cap 16 oz
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852421007393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852421007393008524210073938524210073930852421007393

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical procedure irrigation fluidA solution, typically saline, intended to be used to flush an anatomical site for clearing and cleaning during a surgical/medical procedure (e.g., ocular area during eye surgery, middle ear during an ENT procedure). The solution may be supplied in a prefilled syringe. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume16Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
417-725-3787info@pureandclean.us
214-912-0801drjachterberg@bennetthealth.net

Regulatory Flags#

DUNS number
045315650
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852421007683Pure&Clean1HCQ1HCQ2026-07-29
00852421007850Pure&Clean4HPQ4HPQ2026-07-29
00852421007300Pure&Clean1PW21PW22026-07-22
00852421007331Pure&Clean22.063HP22023-08-11
00852421007348Pure&Clean23.033HP82023-08-11
00852421007461Pure&Clean22.084HP82023-08-11
00852421007577Pure&CleanNone4HP22023-08-11
00852421007669Pure&Clean2020.031HC22023-08-11
00852421007676Pure&Clean2020.041HC82023-08-11
00852421007720Pure&Clean2020.084HPG2023-08-11
00852421007737Pure&Clean2020.081HCG2023-08-11
00852421007027Pure&Clean23.071WC82023-08-04
00852421007034Pure&Clean2016.10.06 A1WC8-RX2023-08-04
00852421007188Pure&Clean2.201WC22023-08-04
00852421007317Pure&Clean22.063LG22023-08-04
00852421007324Pure&Clean22.063LC22023-08-04
00852421007379Pure&CleanNone1WC16-RX2023-08-04
00852421007416Pure&Clean08.20191WC16-RXI2023-08-04
00852421007423Pure&CleanNone1WC16-RXP2023-08-04
00852421007591Pure&Clean08.20191WC8-RXI2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29