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Found 7 results
510(k) Data Aggregation
K Number
K990511Device Name
X-TIP INTRAOSSEOUS PERFORATOR
Manufacturer
SCHIFF & CO.
Date Cleared
1999-04-27
(68 days)
Product Code
DZM
Regulation Number
872.4730Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.
Device Description
Not Found
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K Number
K982136Device Name
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
Manufacturer
SCHIFF & CO.
Date Cleared
1999-03-24
(280 days)
Product Code
DTN
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.
Device Description
Not Found
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K Number
K981629Device Name
NUTRISAFE ENTERAL FEEDING TUBE
Manufacturer
SCHIFF & CO.
Date Cleared
1999-02-04
(273 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.
Device Description
Nutrisafe® Enteral Feeding Tube
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K Number
K981630Device Name
VYGON DOUBLE LUMEN UMBILICAL CATHETER
Manufacturer
SCHIFF & CO.
Date Cleared
1998-10-01
(147 days)
Product Code
FOS
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.
Device Description
Double Lumen Umbilical Catheter
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K Number
K974141Device Name
PLUS REUSABLE RESUSCITATOR
Manufacturer
SCHIFF & CO.
Date Cleared
1998-05-21
(199 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent.
Device Description
Not Found
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K Number
K954448Device Name
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
Manufacturer
SCHIFF & CO.
Date Cleared
1996-10-28
(399 days)
Product Code
FRA
Regulation Number
880.6500Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955085Device Name
HM-CAP EIA TEST (MODIFICATION)
Manufacturer
SCHIFF & CO.
Date Cleared
1996-02-09
(106 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
**SCHIFF **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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