FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098DDS1159D0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
DDS1159D
Catalog number
DDS1159D
Device description
Heart Cath Tray - RX
Published
2026-09-26
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
OESCardiac Catheterization Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098DDS1159D1PackageHIBCC4In Commercial Distribution
B098DDS1159D0PrimaryHIBCC0

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 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
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS195170Aligned Medical SolutionsAMS19517AMS195172026-09-26
B098AMS195240Aligned Medical SolutionsAMS19524AMS195242026-09-26
B098AMS196900Aligned Medical SolutionsAMS19690AMS196902026-09-25
B098AMS197760Aligned Medical SolutionsAMS19776AMS197762026-09-16
B098AMS197870Aligned Medical SolutionsAMS19787AMS197872026-09-02
B098AMS199160Aligned Medical SolutionsAMS19916AMS199162026-09-26
B098AMS199340Aligned Medical SolutionsAMS19934AMS199342026-09-26
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26
B098AMS6160F0Aligned Medical SolutionsAMS6160FAMS6160F2026-09-26
B098AMS9487F0Aligned Medical SolutionsAMS9487FAMS9487F2026-09-26
B098AMS9509E0Aligned Medical SolutionsAMS9509EAMS9509E2026-09-26
B098AMS13148C0Aligned Medical SolutionsAMS13148CAMS13148C2026-09-22
B098AMS191960Aligned Medical SolutionsAMS19196AMS191962026-08-31
B098AMS195690Aligned Medical SolutionsAMS19569AMS195692026-09-21
B098AMS197560Aligned Medical SolutionsAMS19756AMS197562026-09-11
B098AMS198180Aligned Medical SolutionsAMS19818AMS198182026-09-11
B09AMS184330Aligned Medical SolutionsAMS18433AMS184332026-08-31
B098AMS12206A0Aligned Medical SolutionsAMS12206AAMS12206A2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198956572614CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-25