FDA.reportPublic FDA data

DOMREX™ Syringe

Primary DI
00628032000012
Brand
DOMREX™ Syringe
Company
Domrex Pharma Inc
Model
1ml LDS
Published
2024-01-19
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
10628032000019PackageGS18In Commercial Distribution
00628032000012PrimaryGS10
90628032000015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062803200001910628032000019
00628032000012006280320000126280320000120628032000012
9062803200001590628032000015

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA 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 needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It 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
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
00628032333530DOMREX™ Safety Blood Collection Set21G x 3/4” 12'' Luer Adapter2024-01-19

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