FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098DDS61300012110
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
DDS-613000121-1
Catalog number
DDS-613000121-1
Device description
MANIFOLD KIT
Published
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEQAngiography/Angioplasty Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098DDS61300012111PackageHIBCC25In Commercial Distribution
B098DDS61300012110PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18006377056CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
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
00850064198751Aligned Medical Solutions19254S19254S2026-09-23
B098AMS188430Aligned Medical SolutionsAMS18843AMS188432026-09-29
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS167320Aligned Medical SolutionsAMS16732AMS167322026-09-08
B098AMS178940Aligned Medical SolutionsAMS17894AMS178942026-09-28
B098AMS184330Aligned Medical SolutionsAMS18433AMS184332026-09-28
B098AMS192330Aligned Medical SolutionsAMS19233AMS192332026-09-28
B098AMS194460Aligned Medical SolutionsAMS19446AMS194462026-09-28
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS195170Aligned Medical SolutionsAMS19517AMS195172026-09-26
B098AMS195240Aligned Medical SolutionsAMS19524AMS195242026-09-26
B098AMS196900Aligned Medical SolutionsAMS19690AMS196902026-09-25
B098AMS197760Aligned Medical SolutionsAMS19776AMS197762026-09-16
B098AMS197870Aligned Medical SolutionsAMS19787AMS197872026-09-02
B098AMS199160Aligned Medical SolutionsAMS19916AMS199162026-09-26
B098AMS199340Aligned Medical SolutionsAMS19934AMS199342026-09-26
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956509702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956551589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956553583CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581593CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581661CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956588820CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592575CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592681CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596597CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956598188CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
00884450436004Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-29
10198956540491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956542136CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580770CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580978CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956589988CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590625CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590953CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
B098AMS194890Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-09-29
10809160539132HALYARDAVID MEDICAL, INC.OEQ2026-09-28
10198956439849CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956512177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956545991CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956551657CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956556454CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956567948CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956579316CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956581838CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956582293CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25