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Found 15 results
510(k) Data Aggregation
K Number
K981964Device Name
MEDI-TRACE 4103 NEONATAL ELECTRODE
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1998-11-13
(162 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on neonatal and pediatric patients.
Device Description
A neonatal ECG monitoring electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, a foam substrate and vinyl label and a 24 inch lead wire terminating in a 0.059" DIN standard safety socket.
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K Number
K983287Device Name
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1998-11-05
(48 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.
Device Description
A pre-gelled conductive electrode consisting of a pre-attached leadwire, and insulating layer of a vinyl substrate, a secondary vinyl piece covering the crimped wire connector, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive (PSA) ring and a release liner. Device is packaged in pairs in a heat sealed pouch; 10 pouches are packaged into one shelf box shipper.
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K Number
K974730Device Name
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1998-07-14
(208 days)
Product Code
KXO
Regulation Number
884.2700Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.
Device Description
An intrauterine catheter with a pressure transducer at the tip, a thermistor located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.
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K Number
K980857Device Name
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1998-05-12
(68 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.
Device Description
A pre-gelled conductive electrode consisting of a pre-attached leadwire, an insulating layer of a vinyl substrate, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch; 10 pouches are packaged into one shelf box shipper.
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K Number
K972970Device Name
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1997-08-27
(16 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing Electrode is intended for use on adults. Not for use on children or infants.
Device Description
A pre-gelled conductive elecrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel. a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper
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K Number
K964387Device Name
POINT OF USE II SHARPS-A-GATOR
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1997-03-27
(143 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc. The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.
Device Description
Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal. The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions. The top housing assembly and base are made of polypropylene plastic material and processed through injection molding. The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user. The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit. The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container. The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry. The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.
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K Number
K964279Device Name
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1997-01-22
(86 days)
Product Code
KXO
Regulation Number
884.2700Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid.
Device Description
An intrauterine catheter with a pressure transducer at the tip, a port for amnioinfusion and amniotic fluid sampling signal wires, and an introducer which is removed after placement. System includes a reusable cable with a zero mechanism and an attachment strap. Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.
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K Number
K963151Device Name
MEDI-TRACE 5700 RESTING ECG ELECTRODE
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1996-11-19
(102 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963038Device Name
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1996-11-15
(102 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960968Device Name
MEDI-TRACE 200, MEDI-TRACE 200-30
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1996-10-28
(231 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
GRAPHIC CONTROLS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.
Device Description
A conductive wet gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS cyelet, nickel plated brass stud, an adhesive foam substrate, vinyl label and polystyrene release liner. Electrodes are packaged either as 100 per pouch (Medi-Trace® 200) or 30 per pouch (Medi-Trace® 200-30); pouches are heat sealed. Unit of sale for each packaging is a case of either 600 or 1000 electrodes.
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