FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS193710
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19371
Catalog number
AMS19371
Device description
Angio Pack - RX
Published
2026-11-05
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
B098AMS193710PrimaryHIBCC0

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
true
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
B098AMS15842A0Aligned Medical SolutionsAMS15842AAMS15842A2026-11-05
B098AMS16505A0Aligned Medical SolutionsAMS16505AAMS16505A2026-11-05
B098AMS18938A0Aligned Medical SolutionsAMS18938AAMS18938A2026-11-05
B098AMS19018A0Aligned Medical SolutionsAMS19018AAMS19018A2026-11-05
B098AMS195080Aligned Medical SolutionsAMS19508AMS195082026-11-04
B098AMS11396C0Aligned Medical SolutionsAMS11396CAMS11396C2026-11-03
B098AMS126380Aligned Medical SolutionsAMS12638AMS126382026-11-03
B098AMS194900Aligned Medical SolutionsAMS19490AMS194902026-10-02
B098AMS197430Aligned Medical SolutionsAMS19743AMS197432026-10-02
B098AMS202680Aligned Medical SolutionsAMS20268AMS202682026-11-03
B098AMS16175B0Aligned Medical SolutionsAMS16175BAMS16175B2026-10-26
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS14230A0Aligned Medical SolutionsAMS14230AAMS14230A2026-11-02
B098AMS15987A0Aligned Medical SolutionsAMS15987AAMS15987A2026-11-02
B098AMS18754A0Aligned Medical SolutionsAMS18754AAMS18754A2026-11-02
B098AMS18911A0Aligned Medical SolutionsAMS18911AAMS18911A2026-11-02
B098AMS19657A0Aligned Medical SolutionsAMS19657AAMS19657A2026-11-02
B098AMS198930Aligned Medical SolutionsAMS19893AMS198932026-11-02
B098AMS199380Aligned Medical SolutionsAMS19938AMS199382026-10-02
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450099346Merit Medical®Merit Medical Systems, Inc.OEQ2026-11-05
00884450431535Merit Medical®Merit Medical Systems, Inc.OEQ2026-11-05
10198956421349CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956437074CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956494855CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956511132CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956552746CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956568358CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956570719CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956577121CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956590182CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956591806CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956597150CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956599215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956599611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956602779CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956603479CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956604353CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956604391CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956605558CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956606876CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956606906CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956607750CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956607873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956608306CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956609594CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610057CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610415CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610699CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610743CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05