FDA.reportPublic FDA data

Olympus

Primary DI
15019778003344
Brand
Olympus
Company
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
Model
MAJ-1603
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FEQPump, Air, Non-Manual, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019778003344PrimaryGS10
05019778003347Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1501977800334415019778003344
05019778003347050197780033475019778003347

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic irrigation/aspiration pumpA mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
217061423
Device count
3
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15019778008653OlympusARV110K100376162023-10-30
15019778008660OlympusARV120K100376172023-10-30
15019778008677OlympusARV130K100376182023-10-30
15019778008684OlympusARV140K100376192023-10-30
05019778008656OlympusARV110K100376162023-10-30
05019778008663OlympusARV120K100376172023-10-30
05019778008670OlympusARV130K100376182023-10-30
05019778008687OlympusARV140K100376192023-10-30
15019778000879OlympusEndosonic2016-09-19
15019778007700OlympusMAJ-2207K100350022023-07-18
15019778007717OlympusMAJ-2208K100350032023-07-18
15019778007724OlympusMAJ-2209K100350042023-07-18
15019778007731OlympusMAJ-2210K100350052023-07-18
15019778008516OlympusMAJ-2220K100371612023-07-18
15019778008523OlympusMAJ-2221K100371622023-07-18
15019778008530OlympusMAJ-2222K100371632023-07-18
15019778008547OlympusMAJ-2223K100371642023-07-18
15019778008646OlympusWide-Eye Polyp TrapK100376262023-07-18
15019778005072OlympusMAJ-1681K100266412023-07-05
15019778005089OlympusMAJ-1682K100266862023-07-05

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50724995228922DEFENDOMEDIVATORS INC.FEQ2024-01-18
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