Chiwell Biotechnology

GUDID 06979203760278

Ningbo Chiwell Biotechnology Co., Ltd

Frozen tissue fixative IVD

• Primary Device ID: 06979203760278
• NIH Device Record Key: 8d6d15f6-50ac-4e85-ba56-5b2558129062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chiwell Biotechnology
• Version Model Number: 5L
• Company DUNS: 413940020
• Company Name: Ningbo Chiwell Biotechnology Co., Ltd
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06979203760278 [Primary]
GS1	16979203760275 [Package]; Package: carton [4 Units]; In Commercial Distribution

FDA Product Code

• KIP: Formulations, Balanced Salt Solutions

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07

On-Brand Devices [Chiwell Biotechnology]

• 06979203760018: E8
• 06979203760056: CW-800
• 06979203760049: CW-1000
• 06979203760032: CW-1000+CW-800
• 06979203760025: E6
• 06979203760285: 24×50mm
• 06979203760278: 5L