FDA.reportPublic FDA data

Olympus

Primary DI
15019778003542
Brand
Olympus
Company
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
Model
MAJ-1608
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
15019778003542PrimaryGS10
05019778003545Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1501977800354215019778003542
05019778003545050197780035455019778003545

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac ablation system irrigation tubing setA collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217061423
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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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