FDA.reportPublic FDA data

ZYNRELEF Replacement 12 mL Luer Lock Syringes

Primary DI
00347426904087
Brand
ZYNRELEF Replacement 12 mL Luer Lock Syringes
Company
Heron Therapeutics, Inc.
Model
N/A
Catalog number
N/A
Device description
Base package contains quantity of 8 of the 12 mL Luer Lock Syringes.
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00347426904087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00347426904087003474269040873474269040870347426904087

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102099843
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00347426101066SUSTOL Co-packaged KitNA2025-03-18
00347426505086ZYNRELEF 10 mL Vial Access Needle (VAN) ReplacementN/A70016563-002024-11-07
00347426506083ZYNRELEF 20 mL Vial Access Needle (VAN) ReplacementN/A70016564-002024-11-07
00347426505079ZYNRELEF 10 mL Vial Access Needle (VAN)N/A12027-325-312024-10-02
00347426506076ZYNRELEF 20 mL Vial Access Needle (VAN)N/A12027-325-322024-10-02
00347426901017ZYNRELEF Luer Lock ApplicatorN/A7096892021-07-15
00347426902106ZYNRELEF Luer Lock ApplicatorN/A7096892021-07-15
00347426903059ZYNRELEF Replacement Vented Vial SpikesN/AN/A2021-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083045425EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045456EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045555EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045623EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045654EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045722EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045753EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045821EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045852EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00840216124387LiteTouchAsp Global, LLCFMF2026-11-02
00840216124424LiteTouchAsp Global, LLCFMF2026-11-02
00840216124448LiteTouchAsp Global, LLCFMF2026-11-02
00840216124462LiteTouchAsp Global, LLCFMF2026-11-02
00840216123779LiteTouchAsp Global, LLCFMF2026-10-30
00840216123809LiteTouchAsp Global, LLCFMF2026-10-30
00840216123960LiteTouchAsp Global, LLCFMF2026-10-30
00840216123984LiteTouchAsp Global, LLCFMF2026-10-30
00840216124004LiteTouchAsp Global, LLCFMF2026-10-30
00840216124028LiteTouchAsp Global, LLCFMF2026-10-30
00840216124301LiteTouchAsp Global, LLCFMF2026-10-30
00840216124363LiteTouchAsp Global, LLCFMF2026-10-30
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11