NEST BR80213

GUDID 06941854803116

Wuxi Nest Biotechnology Co., Ltd.

Prefilled self-injector, multiple-dose

• Primary Device ID: 06941854803116
• NIH Device Record Key: 4a50885b-3b53-4ced-88ae-4ef050e1bd7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEST
• Version Model Number: NIVR-05
• Catalog Number: BR80213
• Company DUNS: 528156364
• Company Name: Wuxi Nest Biotechnology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	06941854803116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240774

FDA Product Code

• FMF: Syringe, Piston

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: 2025-09-26
• Device Publish Date: 2025-09-18

On-Brand Devices [NEST]

• 06941854803246: NIVR-15
• 06941854803239: NIVR-15
• 06941854803222: NIVR-13
• 06941854803215: NIVR-13
• 06941854803208: NIVR-12
• 06941854803192: NIVR-12
• 06941854803185: NIVR-11
• 06941854803178: NIVR-11
• 06941854803161: NIVR-09
• 06941854803154: NIVR-09
• 06941854803147: NIVR-07
• 06941854803130: NIVR-07
• 06941854803123: NIVR-05
• 06941854803116: NIVR-05
• 06941854802706: NIVR-02
• 06941854802690: NIVR-02