FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS188470
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18847
Catalog number
AMS18847
Device description
Vial Pack - 2pk
Published
2026-10-12
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS188470PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. 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
B098AMS16068A0Aligned Medical SolutionsAMS16068AAMS16068A2026-10-12
B098AMS16554D0Aligned Medical SolutionsAMS16554DAMS16554D2026-09-13
B098AMS188480Aligned Medical SolutionsAMS18848AMS188482026-10-12
B098AMS188490Aligned Medical SolutionsAMS18849AMS188492026-10-12
B098AMS188500Aligned Medical SolutionsAMS18850AMS188502026-10-12
B098AMS188510Aligned Medical SolutionsAMS18851AMS188512026-10-12
B098AMS188520Aligned Medical SolutionsAMS18852AMS188522026-10-12
B098AMS195550Aligned Medical SolutionsAMS19555AMS195552026-10-12
B098AMS197330Aligned Medical SolutionsAMS19733AMS197332026-10-12
B098AMS198150Aligned Medical SolutionsAMS19815AMS198152026-09-11
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26
B098AMS197680Aligned Medical SolutionsAMS19768AMS197682026-09-18
B098AMS12158A0Aligned Medical SolutionsAMS12158AAMS12158A2026-10-11
B098AMS12324E0Aligned Medical SolutionsAMS12324EAMS12324E2026-10-10
B098AMS12325F0Aligned Medical SolutionsAMS12325FAMS12325F2026-10-10
B098AMS15134C0Aligned Medical SolutionsAMS15134CAMS15134C2026-10-10
B098AMS15967C0Aligned Medical SolutionsAMS15967CAMS15967C2026-10-09
B098AMS18164A0Aligned Medical SolutionsAMS18164AAMS18164A2026-10-09
B098AMS18228A0Aligned Medical SolutionsAMS18228AAMS18228A2026-10-10
B098AMS18454A0Aligned Medical SolutionsAMS18454AAMS18454A2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS188480Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188490Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188500Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188510Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188520Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
06971564461696ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
06971564461702ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
00859776006033K-QUE-SAR-SHIPPERQuest DiagnosticsJKA2026-09-15
10197344216123MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-24
30382903679929BD Vacutainer® SST™ Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2026-07-20
10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216130MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216147MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216154MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216161MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216178MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
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00850048720237C-QuestLifeOutcomes LLCJKA2026-07-09
50192253051153CARDINAL HEALTHCardinal Health 200, LLCJKA2026-06-25
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27