FDA.reportPublic FDA data

DOMREX™ Safety needle

Primary DI
00628032025107
Brand
DOMREX™ Safety needle
Company
Domrex Pharma Inc
Model
25Gx1''
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628032025104PackageGS116In Commercial Distribution
00628032025107PrimaryGS10
90628032025100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062803202510410628032025104
00628032025107006280320251076280320251070628032025107
9062803202510090628032025100

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). 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
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

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