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
B098AMS188540Aligned Medical SolutionsAMS18854AMS188542026-09-04
B098AMS191940Aligned Medical SolutionsAMS19194AMS191942026-09-04
B098AMS169560Aligned Medical SolutionsAMS16956AMS169562026-08-25
B098AMS17108C0Aligned Medical SolutionsAMS17108CAMS17108C2026-08-23
B098AMS17526A0Aligned Medical SolutionsAMS17526AAMS17526A2026-08-23
B098AMS185880Aligned Medical SolutionsAMS18588AMS185882026-08-21
B098AMS189100Aligned Medical SolutionsAMS18910AMS189102026-08-21
B098AMS190500Aligned Medical SolutionsAMS19050AMS190502026-08-21
B098AMS190740Aligned Medical SolutionsAMS19074AMS190742026-08-21
B098AMS190750Aligned Medical SolutionsAMS19075AMS190752026-08-21
B098AMS190760Aligned Medical SolutionsAMS19076AMS190762026-08-21
B098AMS192350Aligned Medical SolutionsAMS19235AMS192352026-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
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10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548497CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956549340CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956553217CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
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10198956559684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
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10198956569522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570535CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570573CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571570CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571884CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956572379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04