FDA.reportPublic FDA data

NEST

Primary DI
06941854803192
Brand
NEST
Company
Wuxi Nest Biotechnology Co., Ltd.
Model
NIVR-12
Catalog number
BR80223
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
06941854803192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941854803192069418548031926941854803192

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
06941854803208NESTNIVR-12SR802232025-09-18
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
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02