FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS10132C0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS10132C
Catalog number
AMS10132C
Device description
Angiography Pack
Published
2026-08-03
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
B098AMS10132C1PackageHIBCC6In Commercial Distribution
B098AMS10132C0PrimaryHIBCC0

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
B098AMS16817B0Aligned Medical SolutionsAMS16817BAMS16817B2026-08-03
B098AMS17579A0Aligned Medical SolutionsAMS17579AAMS17579A2026-08-03
B098AMS178930Aligned Medical SolutionsAMS17893AMS178932026-08-03
B098AMS178970Aligned Medical SolutionsAMS17897AMS178972026-08-03
B098AMS186950Aligned Medical SolutionsAMS18695AMS186952026-08-03
B098AMS188600Aligned Medical SolutionsAMS18860AMS188602026-08-03
B098AMS191170Aligned Medical SolutionsAMS19117AMS191172026-08-03
B098AMS12325E0Aligned Medical SolutionsAMS12325EAMS12325E2026-07-27
B098AMS167810Aligned Medical SolutionsAMS16781AMS167812026-07-27
B098AMS190780Aligned Medical SolutionsAMS19078AMS190782026-07-27
B098AMS9909C0Aligned Medical SolutionsAMS9909CAMS9909C2026-07-27
B098AMS131940Aligned Medical SolutionsAMS13194AMS131942026-07-26
B098AMS131950Aligned Medical SolutionsAMS13195AMS131952026-07-26
B098AMS131960Aligned Medical SolutionsAMS13196AMS131962026-07-25
B098AMS13932C0Aligned Medical SolutionsAMS13932CAMS13932C2026-07-25
B098AMS14766B0Aligned Medical SolutionsAMS14766BAMS14766B2026-07-26
B098AMS16019B0Aligned Medical SolutionsAMS16019BAMS16019B2026-07-25
B098AMS17798A0Aligned Medical SolutionsAMS17798AAMS17798A2026-07-26
B098AMS17843A0Aligned Medical SolutionsAMS17843AAMS17843A2026-07-25
B098AMS179150Aligned Medical SolutionsAMS17915AMS179152026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198956541375CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956542402CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
00884450117156Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
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10198956323087CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
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