FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS196180
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19618
Catalog number
AMS19618
Device description
Vascular 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
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS196181PackageHIBCC10In Commercial Distribution
B098AMS196180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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
B098AMS14762A0Aligned Medical SolutionsAMS14762AAMS14762A2026-08-16
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
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
00884450148228Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-19
10809160530795HalyardAVID MEDICAL, INC.OEZ2026-08-19
10198956502512CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956539082CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956548084CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956556881CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557789CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10809160530252HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530337HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530535HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530634HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530665HalyardAVID MEDICAL, INC.OEZ2026-08-18
10198956494800CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956500501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956522619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956535053CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956548770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956549418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550919CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956553293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
00884450467220Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-14