FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS14762A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS14762A
Catalog number
AMS14762A
Device description
Angiography Pack
Published
2026-08-16
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
B098AMS14762A1PackageHIBCC6In Commercial Distribution
B098AMS14762A0PrimaryHIBCC0

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
B098AMS197320Aligned Medical SolutionsAMS19732AMS197322026-08-19
B098AMS188850Aligned Medical SolutionsAMS18885AMS188852026-08-17
B098AMS191930Aligned Medical SolutionsAMS19193AMS191932026-08-17
B098AMS14529C0Aligned Medical SolutionsAMS14529CAMS14529C2026-08-14
B098AMS17107C0Aligned Medical SolutionsAMS17107CAMS17107C2026-08-14
B098AMS17337A0Aligned Medical SolutionsAMS17337AAMS17337A2026-08-14
B098AMS17686A0Aligned Medical SolutionsAMS17686AAMS17686A2026-08-14
B098AMS18377A0Aligned Medical SolutionsAMS18377AAMS18377A2026-08-16
B098AMS188840Aligned Medical SolutionsAMS18884AMS188842026-08-16
B098AMS190240Aligned Medical SolutionsAMS19024AMS190242026-08-16
B098AMS190550Aligned Medical SolutionsAMS19055AMS190552026-08-14
B098AMS191910Aligned Medical SolutionsAMS19191AMS191912026-08-16
B098AMS191990Aligned Medical SolutionsAMS19199AMS191992026-08-14
B098AMS19234A0Aligned Medical SolutionsAMS19234AAMS19234A2026-08-16
B098AMS196180Aligned Medical SolutionsAMS19618AMS196182026-08-16
B098AMS196570Aligned Medical SolutionsAMS19657AMS196572026-08-14
B098AMS196600Aligned Medical SolutionsAMS19660AMS196602026-08-14
B098AMS9246C0Aligned Medical SolutionsAMS9246CAMS9246C2026-08-14
B098AMS10132C0Aligned Medical SolutionsAMS10132CAMS10132C2026-08-03
B098AMS16817B0Aligned Medical SolutionsAMS16817BAMS16817B2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956513563CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956533707CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956536258CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956554580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956555310CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
00884450488843Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-15
B098AMS196570Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-14
B098AMS10132C0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-03
00884450421994Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-01
00884450500927Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-01
10198956433182CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956456891CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956458840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956485266CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956534698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956537033CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538405CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538566CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538658CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956538689CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956540897CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956541375CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956542402CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
00884450117156Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486191Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486207Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450487921Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-29
10198956323087CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956352377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956353572CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27