Primary Device ID | 00861880000340 |
NIH Device Record Key | 44945ae2-c5b5-4547-af1b-067469c5e2a8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Newborn Stem Cell Collection Kit Private kit |
Version Model Number | Private kit |
Company DUNS | 626132575 |
Company Name | CRYO-CELL INTERNATIONAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 8137492188 |
prepacytecustomerservice@cryo-cell.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00861880000340 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-15 |
Device Publish Date | 2019-10-07 |
00861880000333 - PrepaCyte-CB 500 | 2022-01-31 The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n |
00861880000340 - Newborn Stem Cell Collection Kit Private kit | 2019-10-15Newborn Stem Cell Collection Kit for private collection usage |
00861880000340 - Newborn Stem Cell Collection Kit Private kit | 2019-10-15 Newborn Stem Cell Collection Kit for private collection usage |
00861880000357 - Newborn Stem Cell Collection Kit Public Kit | 2019-09-26 Newborn Stem Cell Collection Kit for Public collection usage. |
00861880000364 - Newborn Stem Cell Collection Kit International Kit | 2019-09-26 Newborn Stem Cell Collection Kit for International collection usage. |
00861880000302 - PrepaCyte-CB | 2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc |
00861880000319 - PrepaCyte-CB | 2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc |
00861880000326 - PrepaCyte-CB | 2018-03-29 The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n |