Chiwell Biotechnology

Basic Information

• Brand Name: Chiwell Biotechnology
• Primary DI: 06979203760278
• Version / Model: 5L
• Company Name: Ningbo Chiwell Biotechnology Co., Ltd
• Labeler DUNS: 413940020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-07
• Public Version: 1
• Public Version Date: 2026-01-15
• Public Version Status: New
• Public Device Record Key: 8d6d15f6-50ac-4e85-ba56-5b2558129062

Device Characteristics

• Single Use: No
• 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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIP	Formulations, Balanced Salt Solutions	Hematology	864.2875	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57744	Frozen tissue fixative IVD	A solution intended to be used as a fixative in the processing of frozen tissue sections derived from biological tissues or clinical specimens, for subsequent in vitro diagnostic analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06979203760278	GS1
Package	16979203760275	GS1	carton	4	In Commercial Distribution