FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS142611
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS14261
Catalog number
AMS14261
Device description
CARDIOLOGY EP PACK
Published
2024-01-30
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
B098AMS142611PackageHIBCC6In Commercial Distribution
B098AMS142610PrimaryHIBCC0

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006377056CUSTOMERSERVICE@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
B098AMS10064A1Aligned Medical SolutionsAMS10064AAMS10064A2026-01-09
B098AMS10819A1Aligned Medical SolutionsAMS10819AAMS10819A2026-01-09
B098AMS11635A1Aligned Medical SolutionsAMS11635AAMS11635A2026-01-09
B098AMS12397C1Aligned Medical SolutionsAMS12397CAMS12397C2026-01-09
B098AMS12913A1Aligned Medical SolutionsAMS12913AAMS12913A2026-01-09
B098AMS13295C1Aligned Medical SolutionsAMS13295CAMS13295C2026-01-09
B098AMS13321E1Aligned Medical SolutionsAMS13321EAMS13321E2026-01-09
B098AMS13405D1Aligned Medical SolutionsAMS13405DAMS13405D2026-01-09
B098AMS13432C1Aligned Medical SolutionsAMS13432CAMS13432C2026-01-09
B098AMS14519B1Aligned Medical SolutionsAMS14519BAMS14519B2026-01-09
B098AMS14927C1Aligned Medical SolutionsAMS14927CAMS14927C2026-01-09
B098AMS15157D1Aligned Medical SolutionsAMS15157DAMS15157D2026-01-09
B098AMS15515D1Aligned Medical SolutionsAMS15515DAMS15515D2026-01-09
B098AMS15768A1Aligned Medical SolutionsAMS15768AAMS15768A2026-01-09
B098AMS15798A1Aligned Medical SolutionsAMS15798AAMS15798A2026-01-09
B098AMS15801B1Aligned Medical SolutionsAMS15801BAMS15801B2026-01-09
B098AMS15853A1Aligned Medical SolutionsAMS15853AAMS15853A2026-01-09
B098AMS16553B1Aligned Medical SolutionsAMS16553BAMS16553B2026-01-09
B098AMS16554B1Aligned Medical SolutionsAMS16554BAMS16554B2026-01-09
B098AMS16643B1Aligned Medical SolutionsAMS16643BAMS16643B2026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521816HalyardAVID MEDICAL, INC.OEZ2026-05-26
10809160521823HalyardAVID MEDICAL, INC.OEZ2026-05-26
10198956359949CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956377790CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956382701CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956439337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956442405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956443716CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956453203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956459359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956466333CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956470170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480582CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480827CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956481770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956485211CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486829CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486867CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956487864CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488199CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488335CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488694CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488731CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956489554CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956490413CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
00884450437049Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-23