FDA.reportPublic FDA data

EndoClot

Primary DI
16972011720516
Brand
EndoClot
Company
EndoClot Plus Co.,Ltd.
Model
EPAC-1T
Device description
EndoClot® Air Compressor Connecting Tube
Published
2022-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26972011720513PackageGS110In Commercial Distribution
16972011720516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697201172051326972011720513
1697201172051616972011720516

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, reusableA collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.

Regulatory Flags#

DUNS number
544357082
Device count
1
Premarket exempt
true
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
16972011720219EndoClot SIS-30SIS-302021-02-10
16972011720226EndoClot SIS-152021-06-23
16972011720240EndoClot SISSIS-30-01SIS-30-012021-11-16
16972011720257EndoClot SISSIS-15-01SIS-15-012021-11-16
26972011720513EndoClotEPAC-1T2022-03-18
16972011720011EndoClotEPK2302-012022-03-15
26972011720018EndoClotEPK2302-012022-03-15
16972011720318EndoClot Air CompressorEPAC-22021-06-23
26972011720247EndoClot SISSIS-30-01SIS-30-012021-11-16
26972011720254EndoClot SISSIS-15-01SIS-15-012021-11-16
16972011720028EndoClot PHSEPK2303EPK2303-012021-06-23
16972011720035EndoClot PHSEPK2305EPK2305-012021-06-23
16972011720110EndoClot ApplicatorEA2302021-06-23
26972011720025EndoClot PHSEPK23032021-06-23
26972011720032EndoClot PHSEPK23052021-06-23
46972011720111EndoClot ApplicatorEA2302021-06-23
26972011720223EndoClot SIS-152021-06-23
26972011720315EndoClot Air CompressorEPAC-22021-06-23
26972011720216EndoClot SIS-30SIS-302021-02-10

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