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510(k) Data Aggregation
K Number
K013228Device Name
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
2002-01-18
(113 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to indicate exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes.
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.
Device Description
The 3M Comply 1248 Gas Plasma Chemical Indicator is a sterilization process indicator and is comprised of a blue chemical indicator ink bar printed on a white plastic strip. A comparison color match is also printed on the plastic strip, below the blue indicator ink bar. The chemical indicator changes color from blue to pink upon exposure to vapor hydrogen peroxide in the STERRAD®100, STERRAD®100S and the STERRAD®50 Sterilization processes.
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K Number
K000355Device Name
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
2000-08-23
(201 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000690Device Name
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
2000-05-17
(78 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990482Device Name
3M CLINPRO PROPHY PASTE, MODEL 12611
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
1999-05-13
(86 days)
Product Code
EJR
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
Device Description
3M™ Clinpro™ Prophy Paste is composed of an abrasive, a flavorant, a colorant, and also contains fluoride.
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K Number
K961848Device Name
3M LITTMANN ELECTRONIC STETHOSCOPE
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
1997-09-26
(501 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.
Device Description
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.
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K Number
K965043Device Name
3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
1997-03-10
(83 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
Device Description
The 1830/1830FS is a flat, pleated, tie-on mask consisting of inner and outer cover webs with two different filter webs sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie strings and a malleable plastic coated wire nose piece.
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K Number
K954900Device Name
3M RED DOT ECG LEAD WIRES A
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
1996-07-15
(264 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MINING AND MFG. CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.
Device Description
This device is a patient lead wire. These patient lead wires are manufactured from a variety of electronic conductors, electronic insulating materials, patient end termination and patient lead wire connectors. This variety of materials and assembly configurations is needed to allow for designs that would be disposable, reusable, x-ray translucent or non x-ray translucent. These materials are all typically and commonly used by other companies participating in the market.
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