FDA.reportPublic FDA data

NEST

Primary DI
06941854803208
Brand
NEST
Company
Wuxi Nest Biotechnology Co., Ltd.
Model
NIVR-12
Catalog number
SR80223
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240774000Pen InjectorWuxi Nest Biotechnology Co., Ltd.2024-06-18FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941854803208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941854803208069418548032086941854803208

GMDN Terms#

Term, Definition table
TermDefinition
Prefilled self-injector, multiple-doseA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528156364
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941854802690NESTNIVR-02BR602132025-09-18
06941854802706NESTNIVR-02SR602132025-09-18
06941854803116NESTNIVR-05BR802132025-09-18
06941854803123NESTNIVR-05SR802132025-09-18
06941854803130NESTNIVR-07BR602232025-09-18
06941854803147NESTNIVR-07SR602232025-09-18
06941854803154NESTNIVR-09BR752132025-09-18
06941854803161NESTNIVR-09SR752132025-09-18
06941854803178NESTNIVR-11BR806232025-09-18
06941854803185NESTNIVR-11SR806232025-09-18
06941854803192NESTNIVR-12BR802232025-09-18
06941854803215NESTNIVR-13BR082132025-09-18
06941854803222NESTNIVR-13SR082132025-09-18
06941854803239NESTNIVR-15BR502132025-09-18
06941854803246NESTNIVR-15SR502132025-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14