Insertion Tool

Basic Information

• Brand Name: Insertion Tool
• Primary DI: 07640125650556
• Version / Model: Insertion Tool
• Catalog Number: 7030
• Company Name: Biosafe S.A.
• Labeler DUNS: 488052341
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-18
• Public Version: 6
• Public Version Date: 2023-12-12
• Public Version Status: Update
• Public Device Record Key: 1c40d890-f2d4-4a35-b8c9-640162df8153
• Distribution End Date: 2023-04-26

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAO	Cord Blood Processing System And Storage Container	Hematology	864.9900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45669	Blood centrifugation system containment kit	A collection of sterile devices that is a component of a blood centrifugation system intended to be used during the centrifugation of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), to automatically isolate constituent components (e.g., cells, plasma). The kit is not donor or patient connected and is placed in the centrifuge of the processing unit. It includes a centrifugation chamber into which blood is introduced and sedimented into its components during centrifugation, a stopcock manifold and tubing intended to direct and control the sequential movement of each component, and collection containers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640125650556	GS1
Unit of Use	07640125650648	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK090037	0