FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098PS1001
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
OTC
false
Sterile
false
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

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord blood collection setA group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)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
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS197480Aligned Medical SolutionsAMS19748AMS197482026-09-18
B098AMS12186B0Aligned Medical SolutionsAMS12186BAMS12186B2026-10-05
B098AMS17355A0Aligned Medical SolutionsAMS17355AAMS17355A2026-10-05
B098AMS183880Aligned Medical SolutionsAMS18388AMS183882026-10-05
B098AMS187660Aligned Medical SolutionsAMS18766AMS187662026-10-05
B098AMS188930Aligned Medical SolutionsAMS18893AMS188932026-10-05
B098AMS192280Aligned Medical SolutionsAMS19228AMS192282026-10-05
B098AMS195700Aligned Medical SolutionsAMS19570AMS195702026-09-11
B098AMS197080Aligned Medical SolutionsAMS19708AMS197082026-10-05
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
00850064198751Aligned Medical Solutions19254S19254S2026-09-23
B098AMS188430Aligned Medical SolutionsAMS18843AMS188432026-09-29
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS167320Aligned Medical SolutionsAMS16732AMS167322026-09-08
B098AMS178940Aligned Medical SolutionsAMS17894AMS178942026-09-28
B098AMS184330Aligned Medical SolutionsAMS18433AMS184332026-09-28
B098AMS192330Aligned Medical SolutionsAMS19233AMS192332026-09-28
B098AMS194460Aligned Medical SolutionsAMS19446AMS194462026-09-28

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
B098PS1000Aligned Medical SolutionsAligned Medical SolutionsMYK2018-11-14
10885425366132CARDINAL HEALTHCardinal Health 200, LLCMYK2016-09-27
50885425366130CARDINAL HEALTHCardinal Health 200, LLCMYK2016-09-27