FDA.reportPublic FDA data

CLEAN

Primary DI
06951233720712
Brand
CLEAN
Company
Guangzhou Clean Medical Products Manufacturing Corp.
Model
W-205-02-B(EC)
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06951233720712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951233720712069512337207126951233720712

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/orthopaedic lavage system power supplyA dedicated mains electricity (AC-powered) device designed to convert mains current into the voltage required by a line-powered surgical lavage kit handpiece, to drive its integral pump during surgery to provide a pulsatile jet of sterile fluid (typically saline) to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529707388
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951233720842PALAGUN®CL006-02E(CM194)CL006-02E(CM194)2025-06-05
06951233721610CLEANESTCL006-06A1-02E2024-05-15
06951233721634CLEANESTCL006-06A2-01E2024-05-15
06951233721658CLEANESTCL006-06A2-02E2024-05-15
06951233721665CLEANESTCL006-06B1-01E2024-05-15
06951233721672CLEANESTCL006-06B1-02E2024-05-15
06951233721696CLEANESTCL006-06B2-01E2024-05-15
06951233721719CLEANESTCL006-06B2-02E2024-05-15
06951233721726CLEANESTCL006-06C1-01E2024-05-15
06951233721733CLEANESTCL006-06C1-02E2024-05-15
06951233721757CLEANESTCL006-06C2-01E2024-05-15
06951233721771CLEANESTCL006-06C2-02E2024-05-15
06951233721788CLEANESTCL006-06-17E2024-05-15
06951233721795CLEANESTCL006-06-18E2024-05-15
06951233721603CLEANESTCL006-06A1-01E2024-05-13
04260102136038HeraeusCL006-01-18(CM194)CL006-01-18(CM194)2024-04-11
06951233720125CLEANESTW-202-B(EC)W-202-B(EC)2024-04-11
06951233720170CLEANESTW-202-P3(EC)W-202-P3(EC)2024-04-11
06951233720316CLEANESTW-202-P4(EC)W-202-P4(EC)2024-04-11
06951233720330CLEANESTW-202-P11(EC)W-202-P11(EC)2024-04-11

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