FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS6283A1
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS6283A
Catalog number
AMS6283A
Device description
Cath Pack
Published
2018-11-01
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

Product Codes#

Code, Name table
CodeName
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS6283A1PackageHIBCC6In Commercial Distribution
B098AMS6283A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. 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 intended to be sterilized prior to use.

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
+1(888)637-7056customerservice@alignedmedical

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
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
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20809160517120HalyardAVID MEDICAL, INC.OES2026-03-23
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20809160516956HalyardAVID MEDICAL, INC.OES2026-03-20
50198956404272CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956410518CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956412826CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
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