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510(k) Data Aggregation
K Number
K970739Device Name
RMI HEMOCONCENTRATOR PREFERENCE PACK
Manufacturer
RESEARCH MEDICAL, INC.
Date Cleared
1997-07-08
(130 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
RESEARCH MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack :
- Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A
- Pre-Rinsed BioFilterTM 140 Hemoconcentrator, HEM-001
- 24 inch Hemoconcentrator Tubing Set, TS-024
- 36 inch Hemoconcentrator Tubing Set, TS-036
- Hemoconcentrator Adapter Set, HEM-001 Adapters --
- Hemoconcentrator Waste Bag, WB-001
- BioFilterTM 140 with Adapter Set, HEM-001-A -
- BioFilterTM 140 with 24 inch Tubing Set, HEM-024 (
- BioFilter™ 140 with 36 inch Tubing Set, HEM-036 I
- BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B
- Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B
- Hemoconcentrator Pole Mount, WEW OV
- Hemoconcentrator Pole Mount, HEM-OIH
The hemoconcentrator is intended for relief or mitigation of overhadration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.
Device Description
Not Found
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K Number
K964833Device Name
RMI DUAL FLUID IRRIGATING SYRINGE
Manufacturer
RESEARCH MEDICAL, INC.
Date Cleared
1997-02-19
(79 days)
Product Code
KYZ
Regulation Number
880.6960Why did this record match?
Applicant Name (Manufacturer) :
RESEARCH MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke. The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.
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K Number
K961927Device Name
RMI HEMOCONCENTRACTOR TUBING SET
Manufacturer
RESEARCH MEDICAL, INC.
Date Cleared
1996-08-13
(88 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
RESEARCH MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.
Device Description
The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container. The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.
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K Number
K960098Device Name
RMI INTERNAL MAMMARY ARTERY CANNULA
Manufacturer
RESEARCH MEDICAL, INC.
Date Cleared
1996-03-26
(75 days)
Product Code
DQR
Regulation Number
870.1300Why did this record match?
Applicant Name (Manufacturer) :
RESEARCH MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.
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