FDA.reportPublic FDA data

DOMREX™ Syringe with safety needle

Primary DI
00628032500178
Brand
DOMREX™ Syringe with safety needle
Company
Domrex Pharma Inc
Model
"3ML 22GX1"""
Published
2024-01-21
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
10628032500175PackageGS18In Commercial Distribution
00628032500178PrimaryGS10
90628032500171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062803250017510628032500175
00628032500178006280325001786280325001780628032500178
9062803250017190628032500171

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Regulatory Flags#

DUNS number
242411127
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628032900015DOMREX™ Powder-Free Nitrile Exam GlovesXS2024-01-22
00628032000012DOMREX™ Syringe1ml LDS2024-01-19
00628032000036DOMREX™ Syringe3ML2024-01-19
00628032000050DOMREX™ Syringe5ML2024-01-21
00628032000104DOMREX™ Syringe10ML2024-01-21
00628032025107DOMREX™ Safety needle25Gx1''2024-01-21
00628032125104DOMREX™ Syringe with safety needle1ML2024-01-21
00628032222551DOMREX™ PI GLOVES552024-01-19
00628032222605DOMREX™ PI GLOVES602024-01-19
00628032222650DOMREX™ PI GLOVES652024-01-19
00628032222704DOMREX™ PI GLOVES702024-01-19
00628032222759DOMREX™ PI GLOVES752024-01-19
00628032222803DOMREX™ PI GLOVES802024-01-19
00628032222858DOMREX™ PI GLOVES852024-01-19
00628032222902DOMREX™ PI GLOVES902024-01-19
00628032325108DOMREX™ Syringe with safety needle3ML2024-01-21
00628032333370DOMREX™ Safety Blood Collection Set21G x 3/4” 12'' 2024-01-19
00628032333387DOMREX™ Safety Blood Collection Set23G x 3/4” 12'' 2024-01-19
00628032333431DOMREX™ Safety Blood Collection Set21G x 3/4” 12'' Holder2024-01-19
00628032333448DOMREX™ Safety Blood Collection Set23G x 3/4” 12'' Holder2024-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01