FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098PS1000
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
PS100
Catalog number
PS100
Device description
Cord Blood Collection Set
Published
2018-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYKKit, cord blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYKKit, Cord Blood CollectionUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098PS1001PackageHIBCC30In Commercial Distribution
B098PS1000PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

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
10195594402969CARDINAL HEALTHCardinal Health 200, LLCMYK2021-10-20
50195594402967CARDINAL HEALTHCardinal Health 200, LLCMYK2021-10-20
10888439509298CARDINAL HEALTHCardinal Health 200, LLCMYK2019-05-31
50888439509296CARDINAL HEALTHCardinal Health 200, LLCMYK2019-05-31
B098PS1001Aligned Medical SolutionsAligned Medical SolutionsMYK2018-11-14
10885425366132CARDINAL HEALTHCardinal Health 200, LLCMYK2016-09-27
50885425366130CARDINAL HEALTHCardinal Health 200, LLCMYK2016-09-27