Celling Cardio Application Kit

Basic Information

• Brand Name: Celling Cardio Application Kit
• Primary DI: 00817771028849
• Version / Model: 0851-0003
• Catalog Number: 0851-0003
• Company Name: Celling Biosciences
• Labeler DUNS: 021560394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-11
• Public Version: 1
• Public Version Date: 2025-04-21
• Public Version Status: New
• Public Device Record Key: 0b6a72ca-bbc2-41db-902b-f214f31a8783

Device Description

Celling Cardio Application Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
IQG	Adaptor, Holder, Syringe	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65764	Surgical dual-component administration set	A collection of non-powered devices consisting of a dual-barrel syringe, each barrel calibrated to different volumes, with attachable vial/bottle adaptors to withdraw and mixing units to administer a two-component liquid (e.g., tissue reconstructive product) in a specific ratio (e.g., 4:1) during surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817771028849	GS1

Customer Contacts

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