FDA.reportPublic FDA data

Ecomed Angiographic

Primary DI
10855009006150
Brand
Ecomed Angiographic
Company
ECOMED SOLUTIONS, LLC
Model
128-100101
Catalog number
128-100101
Device description
CT 200mL MA Syringe Kit Includes (1) 60" coiled tubing (1) fill straw
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
10855009006150PackageGS150In Commercial Distribution
00855009006153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085500900615010855009006150
00855009006153008550090061538550090061530855009006153

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Inch

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
true
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
10855009006051Ecomed Angiographic128-I90107128-I901072017-09-21
10855009006105Ecomed Angiographic128-200301128-2003012017-09-21
10855009006112Ecomed Angiographic128-200301A128-200301A2017-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
10193489065824NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066029NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066043NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066081NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
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
10193489065916NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066067NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066104NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066142NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066159NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065848NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065855NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065886NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065893NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065923NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065930NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065947NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065954NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065961NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065978NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065985NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065992NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05