FDA.reportPublic FDA data

ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement

Primary DI
00347426505086
Brand
ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
Company
Heron Therapeutics, Inc.
Model
N/A
Catalog number
70016563-00
Device description
ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
Published
2024-11-07
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
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00347426505086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00347426505086003474265050863474265050860347426505086

GMDN Terms#

Term, Definition table
TermDefinition
Vial/bottle adaptor, non-hermeticA device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00347426101066SUSTOL Co-packaged KitNA2025-03-18
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
00347426904087ZYNRELEF Replacement 12 mL Luer Lock SyringesN/AN/A2021-07-15

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