FDA.reportPublic FDA data

ZYNRELEF Luer Lock Applicator

Primary DI
00347426902106
Brand
ZYNRELEF Luer Lock Applicator
Company
Heron Therapeutics, Inc.
Model
N/A
Catalog number
709689
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00347426902106PackageGS110In Commercial Distribution
00347426901017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00347426902106003474269021063474269021060347426902106
00347426901017003474269010173474269010170347426901017

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102099843
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00347426903059ZYNRELEF Replacement Vented Vial SpikesN/AN/A2021-07-15
00347426904087ZYNRELEF Replacement 12 mL Luer Lock SyringesN/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