FDA.reportPublic FDA data

Ecomed Angiographic

Primary DI
10855009006051
Brand
Ecomed Angiographic
Company
ECOMED SOLUTIONS, LLC
Model
128-I90107
Catalog number
128-I90107
Device description
90" Coiled Extension Tubing, high pressure
Published
2017-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855009006051PackageGS150In Commercial Distribution
00855009006054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085500900605110855009006051
00855009006054008550090060548550090060540855009006054

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure300Pound per Square Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)817-7114onestop@ecomed-solutions.com

Regulatory Flags#

DUNS number
079814353
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855009006092SureglideECO158005ECO1580052017-09-21
00855009006009Ecomed Angiographic128-200101128-2001012017-09-21
00855009006016Ecomed Angiographic128-200107D128-200107D2017-09-21
00855009006023Ecomed Angiographic128-100302128-1003022017-09-21
00855009006047Ecomed Angiographic128-T60012128-T600122017-09-21
00855009006054Ecomed Angiographic128-I90107128-I901072017-09-21
00855009006108Ecomed Angiographic128-200301128-2003012017-09-21
00855009006115Ecomed Angiographic128-200301A128-200301A2017-09-21
00855009006122Ecomed Angiographic128-100301128-1003012017-09-21
00855009006139Ecomed Angiographic128-200201128-2002012017-09-21
00855009006146Ecomed Angiographic128-100201128-1002012017-09-21
00855009006153Ecomed Angiographic128-100101128-1001012017-09-21
10855009006006Ecomed Angiographic128-200101128-2001012017-09-21
10855009006013Ecomed Angiographic128-200107D128-200107D2017-09-21
10855009006020Ecomed Angiographic128-100302128-1003022017-09-21
00855009006030Ecomed Angiographic128-I60195128-I601952017-09-21
10855009006044Ecomed Angiographic128-T60012128-T600122017-09-21
10855009006105Ecomed Angiographic128-200301128-2003012017-09-21
10855009006112Ecomed Angiographic128-200301A128-200301A2017-09-21
10855009006129Ecomed Angiographic128-100301128-1003012017-09-21

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Primary DI, Brand, Company table
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09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
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