FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS188500
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18850
Catalog number
AMS18850
Device description
Vial Pack - 8pk
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
B098AMS188500PrimaryHIBCC0

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
B098AMS14230A0Aligned Medical SolutionsAMS14230AAMS14230A2026-11-02
B098AMS15987A0Aligned Medical SolutionsAMS15987AAMS15987A2026-11-02
B098AMS18754A0Aligned Medical SolutionsAMS18754AAMS18754A2026-11-02
B098AMS18911A0Aligned Medical SolutionsAMS18911AAMS18911A2026-11-02
B098AMS19657A0Aligned Medical SolutionsAMS19657AAMS19657A2026-11-02
B098AMS198930Aligned Medical SolutionsAMS19893AMS198932026-11-02
B098AMS199380Aligned Medical SolutionsAMS19938AMS199382026-10-02
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14091A0Aligned Medical SolutionsAMS14091AAMS14091A2026-10-30
B098AMS16554E0Aligned Medical SolutionsAMS16554EAMS16554E2026-10-30
B098AMS17150C0Aligned Medical SolutionsAMS17150CAMS17150C2026-10-31
B098AMS196630Aligned Medical SolutionsAMS19663AMS196632026-10-31
B098AMS198900Aligned Medical SolutionsAMS19890AMS198902026-10-31
B098AMS200760Aligned Medical SolutionsAMS20076AMS200762026-10-30
B098AMS201290Aligned Medical SolutionsAMS20129AMS201292026-10-30
B098AMS202330Aligned Medical SolutionsAMS20233AMS202332026-10-30
B098AMS4331D0Aligned Medical SolutionsAMS4331DAMS4331D2026-10-30
B098AMS194040Aligned Medical SolutionsAMS19404AMS194042026-10-23
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS188470Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188480Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188490Aligned 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
10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720466C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720558C-QuestLifeOutcomes LLCJKA2026-07-14
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