Newborn Stem Cell Collection Kit Private kit

Basic Information

• Brand Name: Newborn Stem Cell Collection Kit Private kit
• Primary DI: 00861880000340
• Version / Model: Private kit
• Company Name: CRYO-CELL INTERNATIONAL, INC.
• Labeler DUNS: 626132575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-07
• Public Version: 1
• Public Version Date: 2019-10-15
• Public Version Status: New
• Public Device Record Key: 44945ae2-c5b5-4547-af1b-067469c5e2a8

Device Description

Newborn Stem Cell Collection Kit for private collection usage

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
47115	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861880000340	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]