FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS19657A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19657A
Catalog number
AMS19657A
Device description
Angio Pack
Published
2026-11-02
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
B098AMS19657A0PrimaryHIBCC0

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
B098AMS14230A0Aligned Medical SolutionsAMS14230AAMS14230A2026-11-02
B098AMS15987A0Aligned Medical SolutionsAMS15987AAMS15987A2026-11-02
B098AMS18754A0Aligned Medical SolutionsAMS18754AAMS18754A2026-11-02
B098AMS18911A0Aligned Medical SolutionsAMS18911AAMS18911A2026-11-02
B098AMS198930Aligned Medical SolutionsAMS19893AMS198932026-11-02
B098AMS199380Aligned Medical SolutionsAMS19938AMS199382026-10-02
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14091A0Aligned Medical SolutionsAMS14091AAMS14091A2026-10-30
B098AMS16554E0Aligned Medical SolutionsAMS16554EAMS16554E2026-10-30
B098AMS17150C0Aligned Medical SolutionsAMS17150CAMS17150C2026-10-31
B098AMS196630Aligned Medical SolutionsAMS19663AMS196632026-10-31
B098AMS198900Aligned Medical SolutionsAMS19890AMS198902026-10-31
B098AMS200760Aligned Medical SolutionsAMS20076AMS200762026-10-30
B098AMS201290Aligned Medical SolutionsAMS20129AMS201292026-10-30
B098AMS202330Aligned Medical SolutionsAMS20233AMS202332026-10-30
B098AMS4331D0Aligned Medical SolutionsAMS4331DAMS4331D2026-10-30
B098AMS194040Aligned Medical SolutionsAMS19404AMS194042026-10-23
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS13148C0Aligned Medical SolutionsAMS13148CAMS13148C2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450436936Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-30
B098AMS202330Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-30
00884450254677Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-29
10198956560505CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956568075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956586154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956588646CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956590052CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956610682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956611221CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956615342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618640CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618725CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619630CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619852CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956621336CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622418CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622425CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
00884450429150Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-27
10809160541814Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-27
10198956605091CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956607590CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956610873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956620322CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
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