CellSave

Basic Information

• Brand Name: CellSave
• Primary DI: 10888385000047
• Version / Model: 7900005
• Catalog Number: 7900005
• Company Name: MENARINI SILICON BIOSYSTEMS, INC.
• Labeler DUNS: 057722858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: c42a8f2d-87f9-4d63-94dc-70387e995cb4

Device Description

Preservative Tube 100 Pack

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45805	Evacuated blood collection tube IVD, Na2EDTA	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant disodium ethylene diamine tetraacetic acid (Na2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood trace-element, toxicology, and nutritional-chemistry determinations). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888385000044	GS1	Case	1000	In Commercial Distribution
Primary	10888385000047	GS1
Unit of Use	80888385000046	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if the additive is not clear and colorless
• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius