3D Bag Set

Basic Information

• Brand Name: 3D Bag Set
• Primary DI: 00886368000148
• Version / Model: 80105
• Company Name: Thermogenesis Corp.
• Labeler DUNS: 080690327
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2021-10-04
• Public Version: 1
• Public Version Date: 2021-10-12
• Public Version Status: New
• Public Device Record Key: 536a33bc-0029-4243-96c4-5103ed9dc618

Device Description

3D Bag Set

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16534	Cryobiological storage container	A super-insulated vessel designed to store cryobiological specimens (frozen tissues/organs), typically with the use of liquid nitrogen (LN2), for an indefinite period. The device is typically designed to store multiple specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886368000148	GS1
Unit of Use	00886368000131	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius