FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS188920
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18892
Catalog number
AMS18892
Device description
Cath Pack
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B098AMS188921PackageHIBCC6In Commercial Distribution
B098AMS188920PrimaryHIBCC0

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 Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-800-637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags#

DUNS number
106580145
Device count
1
DM exempt
false
Premarket exempt
true
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
B098AMS12195E0Aligned Medical SolutionsAMS12195EAMS12195E2026-10-23
B098AMS16041C0Aligned Medical SolutionsAMS16041CAMS16041C2026-10-02
B098AMS16179A0Aligned Medical SolutionsAMS16179AAMS16179A2026-10-23
B098AMS173690Aligned Medical SolutionsAMS17369AMS173692026-10-23
B098AMS191190Aligned Medical SolutionsAMS19119AMS191192026-10-23
B098AMS191900Aligned Medical SolutionsAMS19190AMS191902026-10-23
B098AMS19291A0Aligned Medical SolutionsAMS19291AAMS19291A2026-10-23
B098AMS194040Aligned Medical SolutionsAMS19404AMS194042026-10-23
B098AMS194050Aligned Medical SolutionsAMS19405AMS194052026-10-23
B098AMS197690Aligned Medical SolutionsAMS19769AMS197692026-10-23
B098AMS199310Aligned Medical SolutionsAMS19931AMS199312026-10-23
B098AMS199320Aligned Medical SolutionsAMS19932AMS199322026-10-23
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23
B098AMS199880Aligned Medical SolutionsAMS19988AMS199882026-10-23
B098AMS199890Aligned Medical SolutionsAMS19989AMS199892026-10-23
B098AMS201510Aligned Medical SolutionsAMS20151AMS201512026-10-23
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS195290Aligned Medical SolutionsAMS19529AMS195292026-10-02
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956590229CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956603837CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956606982CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608016CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608214CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956609068CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956612730CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956614918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616738CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
B098AMS199310Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
00884450499214Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450501023Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450502082Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450431641Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-21
10809160541029Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-21
10198956513587CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956553422CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956591677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956594395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956607712CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956608641CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956611320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613294CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19