Home GUDID B098PS1001 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
Product Codes# Code, Name table Code Name MYK Kit, cord blood collection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MYK Kit, Cord Blood Collection Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B098PS1001 Package HIBCC 30 In Commercial Distribution B098PS1000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Umbilical cord blood collection set A 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 Type Low High Condition Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius
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 DI Brand Model Catalog Published B098AMS131940 Aligned Medical Solutions AMS13194 AMS13194 2026-07-26 B098AMS131950 Aligned Medical Solutions AMS13195 AMS13195 2026-07-26 B098AMS131960 Aligned Medical Solutions AMS13196 AMS13196 2026-07-25 B098AMS13932C0 Aligned Medical Solutions AMS13932C AMS13932C 2026-07-25 B098AMS14766B0 Aligned Medical Solutions AMS14766B AMS14766B 2026-07-26 B098AMS16019B0 Aligned Medical Solutions AMS16019B AMS16019B 2026-07-25 B098AMS17798A0 Aligned Medical Solutions AMS17798A AMS17798A 2026-07-26 B098AMS17843A0 Aligned Medical Solutions AMS17843A AMS17843A 2026-07-25 B098AMS179150 Aligned Medical Solutions AMS17915 AMS17915 2026-07-26 B098AMS18256A0 Aligned Medical Solutions AMS18256A AMS18256A 2026-07-25 B098AMS187260 Aligned Medical Solutions AMS18726 AMS18726 2026-07-25 B098AMS188360 Aligned Medical Solutions AMS18836 AMS18836 2026-07-26 B098AMS189110 Aligned Medical Solutions AMS18911 AMS18911 2026-07-26 B098AMS190180 Aligned Medical Solutions AMS19018 AMS19018 2026-07-26 B098AMS190570 Aligned Medical Solutions AMS19057 AMS19057 2026-07-25 B098AMS190730 Aligned Medical Solutions AMS19073 AMS19073 2026-07-26 B098AMS190920 Aligned Medical Solutions AMS19092 AMS19092 2026-07-26 B098AMS190930 Aligned Medical Solutions AMS19093 AMS19093 2026-07-26 B098AMS193930 Aligned Medical Solutions AMS19393 AMS19393 2026-07-26 B098AMS194550 Aligned Medical Solutions AMS19455 AMS19455 2026-07-26
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