FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS192350
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19235
Catalog number
AMS19235
Device description
Loop Recorder Pack
Published
2026-08-21
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
B098AMS192351PackageHIBCC6In Commercial Distribution
B098AMS192350PrimaryHIBCC0

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
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
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
B098AMS18377A0Aligned Medical SolutionsAMS18377AAMS18377A2026-08-16
B098AMS188840Aligned Medical SolutionsAMS18884AMS188842026-08-16
B098AMS190240Aligned Medical SolutionsAMS19024AMS190242026-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531907HalyardAVID MEDICAL, INC.OEZ2026-08-27
10809160532072HalyardAVID MEDICAL, INC.OEZ2026-08-27
00884450437766Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-26
10198956346246CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956473836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956532243CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956534810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956542266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956542730CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956545816CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956547858CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956548138CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956549951CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956557314CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956559295CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956560963CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561755CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561786CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562158CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562165CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562318CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562868CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563353CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563407CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563711CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563971CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10809160531808HalyardAVID MEDICAL, INC.OEZ2026-08-26
00884450432082Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-25