NEST

Basic Information

• Brand Name: NEST
• Primary DI: 06941854802706
• Version / Model: NIVR-02
• Catalog Number: SR60213
• Company Name: Wuxi Nest Biotechnology Co., Ltd.
• Labeler DUNS: 528156364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-18
• Public Version: 1
• Public Version Date: 2025-09-26
• Public Version Status: New
• Public Device Record Key: 28822be6-3807-44d6-b6e4-bb4621bbfd00

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: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67132	Prefilled self-injector, multiple-dose	A non-powered hand-held device, commonly known as a pen injector, which is prefilled with a pharmaceutical agent (e.g., insulin, anti-rheumatic drug) and is intended to be used by a patient or carer for regular injection of a dose of the pharmaceutical into subcutaneous or muscle tissue via a replaceable needle. It is in the form of a spring-loaded pen, typically with a dial for dosing, whereby the drug is administered through manual application of pressure on the injection site. Procedural supportive devices (e.g., antiseptic wipes) may be included with the injector. This device is reusable until the contents of the syringe are exhausted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06941854802706	GS1

Premarket Submissions

Submission Number	Supplement Number
K240774	000