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Found 11 results
510(k) Data Aggregation
K Number
K083417Device Name
INTRATEMP SOLUTION WARMER
Manufacturer
C CHANGE SURGICAL LLC
Date Cleared
2009-01-13
(56 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.
Device Description
Not Found
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K Number
K080609Device Name
SWC/DWC WARMING CABINETS
Manufacturer
MAC MEDICAL
Date Cleared
2008-06-13
(102 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
Device Description
These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.
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K Number
K050524Device Name
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
Manufacturer
MARDA MEDICAL, INC.
Date Cleared
2005-09-14
(196 days)
Product Code
IRQ
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.
Device Description
The EZ-IV Medical Pad Warming Unit, is a compact, portable, tabletop size medical device, used to warm factory sealed medical prep pads (alcohol and povidone iodine), with a pre-set maximum temperature of 55° C. A lid covers the unit to minimize any heat loss from the medical pads. Inside the unit are four individual compartments, in which the sealed pads are placed. Each compartment has it's own, inner lid. The front of the device has a membrane keypad to control the device function.
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K Number
K051819Device Name
C CHANGE SOLUTION WARMER
Manufacturer
C CHANGE SURGICAL LLC
Date Cleared
2005-08-15
(41 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Device Description
The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via an oblique (OLIF) approach: a
- as a single device via a transforaminal (TLIF) approach: or -
- as as a single device via an anterior or anterolateral (ALIF) approach.
The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
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K Number
K023282Device Name
ORS-3000LD
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-11-13
(43 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.
Device Description
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile.
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K Number
K023283Device Name
1075LD HUSH-SLUSH
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-11-13
(43 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.
Device Description
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K Number
K021288Device Name
ORS-1000LD
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-06-27
(65 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.
Device Description
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.
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K Number
K021289Device Name
WARMER 2000LD
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-06-26
(64 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.
Device Description
Not Found
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K Number
K002859Device Name
SSW-STERILE SOLUTION WARMER
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2000-11-16
(64 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.
Device Description
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K Number
K965136Device Name
UROSURGE UROTHERM FLUID WARMING SYSTEM
Manufacturer
PRINCETON REGULATORY ASSOC.
Date Cleared
1998-10-16
(662 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.
Device Description
UroSurge UroTherm™ Fluid Warning System
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