FDA.reportPublic FDA data

Bactisure™

Primary DI
00864076000292
Brand
Bactisure™
Company
NEXT SCIENCE, LLC
Model
00-8887-002-00
Published
2020-12-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K161165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161165000Next Science Irrigation SolutionNext Science, LLC2016-09-07FQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864076000292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864076000292008640760002928640760002920864076000292

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, sterileA sterile solution that includes an antimicrobial agent [e.g., polyhexanide (PHMB)] intended to be used to irrigate, clean/moisten, and decontaminate a wound or burn to aid in autolytic debridement, and to moisten/lubricate a wound dressing. It may be used for acute or chronic wounds, including first or second degree burns. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-564-2762info@nextscience.com

Regulatory Flags#

DUNS number
043989331
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10370858000147XPERIENCEMC-SL-0005-102021-04-28
20370858000144XPERIENCEMC-SL-0005-42021-04-28
00370858000225XPERIENCEMC-SL-0005-10D2021-04-28
00370858000232XPERIENCEMC-SL-0005-4D2021-04-28
00370858000355BlastXWG-00032025-04-14
00370858000010BIOWASH Surgical IrrigationBW05002024-07-31
00370858000058BIOWASH Surgical IrrigationBW0500-42024-07-31
00370858000218XPERIENCEMC-SL-0005-1D2021-04-28
00864076000216BlastX™WG-00012018-07-24
00864076000285BlastX™MC-WG-0003-122018-08-15
00370858000041SurgX™MC-WG-0010-82018-09-20
00370858000072BlastX™MC-WG-0011-302018-09-25
00370858000089BlastX™MC-WG-0003-402018-09-25
00370858000096BlastX™MC-WG-0003-802018-09-25
00370858000270SITEGUARDMC-SL-0008-102022-03-01
00370858000164TridentXMC-WW-0005-3202022-06-01
00370858000140XPERIENCEMC-SL-0005-42021-04-28
00864076000209Bactisure™00-8887-001-002018-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
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
03600040955086ElefantColoplast A/SFQH2024-04-05
03600040955116ElefantColoplast A/SFQH2024-04-05
03600040970614ElefantColoplast A/SFQH2024-04-05
03600040970645ElefantColoplast A/SFQH2024-04-05
03600040970676ElefantColoplast A/SFQH2024-04-05
03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
00034197018470Premier Solution Saline Wound WashPremier Brands of America Inc.FQH2024-03-12
00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10