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
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS195290Aligned Medical SolutionsAMS19529AMS195292026-10-02
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14994B0Aligned Medical SolutionsAMS14994BAMS14994B2026-10-16
B098AMS15543A0Aligned Medical SolutionsAMS15543AAMS15543A2026-10-16
B098AMS16588B0Aligned Medical SolutionsAMS16588BAMS16588B2026-10-16
B098AMS16589C0Aligned Medical SolutionsAMS16589CAMS16589C2026-10-16
B098AMS16935A0Aligned Medical SolutionsAMS16935AAMS16935A2026-10-16
B098AMS17680A0Aligned Medical SolutionsAMS17680AAMS17680A2026-10-16
B098AMS18304A0Aligned Medical SolutionsAMS18304AAMS18304A2026-10-16
B098AMS197790Aligned Medical SolutionsAMS19779AMS197792026-10-16
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
B098AMS1218F0Aligned Medical SolutionsAMS1218FAMS1218F2026-10-14
B098AMS14689D0Aligned Medical SolutionsAMS14689DAMS14689D2026-10-14
B098AMS14856B0Aligned Medical SolutionsAMS14856BAMS14856B2026-10-14
B098AMS16398B0Aligned Medical SolutionsAMS16398BAMS16398B2026-10-14
B098AMS17118A1Aligned Medical SolutionsAMS17118AAMS17118A2026-10-14
B098AMS17481A0Aligned Medical SolutionsAMS17481AAMS17481A2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956518964CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956584419CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956590298CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956608702CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10809160540688HalyardAVID MEDICAL, INC.OES2026-10-16
10198956606203CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-13
10809160540596HalyardAVID MEDICAL, INC.OES2026-10-13
10198956592766CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956597518CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598416CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598522CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598539CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602311CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602748CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10809160540145HalyardAVID MEDICAL, INC.OES2026-10-08
10198956593817CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956593930CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956596016CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956598546CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956601062CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10809160539545HalyardAVID MEDICAL, INC.OES2026-10-01
10198956488847CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956516946CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956592308CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956593459CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956596641CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10809160539477HalyardAVID MEDICAL, INC.OES2026-09-30
10198956461963CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-29
10809160539262HalyardAVID MEDICAL, INC.OES2026-09-29
B098AMS194460Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-28