FDA.reportPublic FDA data

Affinity Home with accessories

Primary DI
07290017249063
Brand
Affinity Home with accessories
Company
TAVGER LTD
Model
FG00016
Device description
Affinity G.J.S with accessories MP
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07290017249063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017249063072900172490637290017249063

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/orthopaedic lavage control unitA mains electricity (AC-powered) device designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) by regulating a pulsatile jet of sterile fluid (typically saline). It is typically an electromechanical unit that includes a pump for irrigation/infusion of fluids, an extractor (frequently using vacuum), and controls for the rate of irrigation/infusion and withdrawal of the fluid; it usually operates with separate kits that include handpieces, tubing, and detachable tips (applicators) of various shapes and sizes for specific surgical applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533284357
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017249032MesoStripFG000102022-03-24
07290017249049BioRef-DCFG000192022-03-24
07290017249056Affinity G.J.S with accessories FG000142022-03-24
07290017249070Handpiece Affinity G.J.SFG000222022-03-24
07290017249001Affinity with accessoriesFG000042017-07-07
07290017249018Disposable tips boxFG000062017-07-07
07290017249002Disposable tips boxAFHP250012017-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056880636BactisureOSARTIS GmbHFQH2026-08-25
00850022135316VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135330VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135347VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
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
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
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
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720170CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11