AXP Disposable Processing Bagset

Basic Information

• Brand Name: AXP Disposable Processing Bagset
• Primary DI: 00886368000308
• Version / Model: 8-5101
• Company Name: Thermogenesis Corp.
• Labeler DUNS: 080690327
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2021-01-12
• Public Version Status: Update
• Public Device Record Key: 62d507a8-f0ab-4595-a2c2-2ccfa4eb48d7

Device Description

Cord blood processing system and storage container

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
OAO	Cord Blood Processing System And Storage Container	Hematology	864.9900	2

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
Package	10886368000305	GS1	Case	24	In Commercial Distribution
Primary	00886368000308	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK070006	0

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 15 deg C - 30 deg C, Keep dry