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510(k) Data Aggregation
K Number
K102572Device Name
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
Manufacturer
Date Cleared
2010-12-27
(110 days)
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
SAINATH INTELLECTUAL PROPERTIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IYUNNI" 3ID Suprapubic Cystostomy Kit is indicated for use in suprapubic bladder catherization and drainage of fluids to and from the urinary tract.
Device Description
The kit consists of two major components: IYUNNI™ Suprapubic Cystostomy Tube and IYUNNI™ Soft Collar Introducer Dilator. The kit is used for percutaneous bladder drainage.
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K Number
K100173Device Name
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
Manufacturer
Date Cleared
2010-04-16
(85 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
SAINATH INTELLECTUAL PROPERTIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IYUNNI™ 31D Tri-Funnel Feeding Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract. The gastrostomy tube may also be used for gastric decompression.
Device Description
The IYUNNI™ 31D Tri-Funnel Gastrostomy Tube Kit is a percutaneous endoscopic gastrostomy tube kit comprising the Bard® Tri-Funnel Gastrostomy Tube along with the IYUNNI™ Soft Tip Introducer Dilator. Now, SaiNath Intellectual Properties intends to introduce its own gastrostomy tube as part of this kit. The Bard® Tri-Funnel Gastrostomy Tube is an all silicone tube with a balloon as the internal bolster and a silicone external bolster. The TYUNNI™ 3ID Tri-Funnel Feeding Tube kit will include, in addition to a gastrostomy tube the IYUNNI™ Soft Tip Introducer Dilator and a silicone external bolster.
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K Number
K092049Device Name
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT
Manufacturer
Date Cleared
2009-10-09
(94 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
SAINATH INTELLECTUAL PROPERTIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression.
Device Description
The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is a gastrostomy tube kit. The kit components include the IYUNNI™ Soft Tip Introducer Dilator.
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