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510(k) Data Aggregation
K Number
K080174Device Name
PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
Manufacturer
Date Cleared
2008-04-23
(90 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMED SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CMS Phlebotomy Bag Sets are described as devices intended to control the collection and disposal of blood, from a peripheral vein and into a container( bag) for safe removal and disposal.
Device Description
Not Found
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K Number
K042672Device Name
14F DUAL FLOATING DIALYSIS CATHETER/TRAY
Manufacturer
Date Cleared
2005-03-23
(175 days)
Product Code
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMED SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CMS Dual Floating Dialysis Catheters are indicated for use in attaining vascular access sites for Hemodialysis and Apheresis treatments. The device is attended to be inserted into the internal jugular vein of an adult patient. Catheter greater than 40cm are intended for femoral vein insertion
Alternate insertion site is the subclavian vein as required. This catheter is indicated for duration not to exceed 12 months
Device Description
CardioMed-CMS 14F Dual Floating Dialysis Catheters
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K Number
K021080Device Name
NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
Manufacturer
Date Cleared
2002-08-29
(148 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CARDIOMED SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CMS Noncor Infusion Set(s) with or without Injection Site are designed for easy insertion into vascular access devices for safe administration of continuous and/or bolus infusion of pain control medications, chemotherapeutic agents and pharmaceuticals. CMS Noncor infusion set(s) are available in all commonly used needle gauges and lengths, sets include macrobore or microbore tubing with or without injection site.
Device Description
CMS Noncor Infusion Set(s) and CMS Noncor Infusion Set(s) with Injection Site
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