FDA.reportPublic FDA data

Medtfine

Primary DI
M992304131803
Brand
Medtfine
Company
Carelife (usa) Inc.
Model
1
Catalog number
30-41-3180
Device description
Safety Pen Needles 31G*8mm
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
M992304131805PackageHIBCC12In Commercial Distribution
M992304131803PrimaryHIBCC0
M992304131800Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge31Gauge

Contacts#

Phone, Email table
PhoneEmail
7709356499li@carelifeusa.com

Regulatory Flags#

DUNS number
065756949
Device count
100
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
M992CTIS2811CareTouch1CTIS2812023-02-07
M992CTIS3011CareTouch1CTIS3012023-02-07
M992CTIS3051CareTouch1CTIS3052023-02-07
M992CTIS3111CareTouch1CTIS3112023-02-07
M992CTIS3131CareTouch1CTIS3132023-02-07
M992CTIS3151CareTouch1CTIS3152023-02-07
00857513006483US DIAGNOSTICS18-57513-00648-32023-07-17
00857513006506US DIAGNOSTICS18-57513-00650-62023-07-17
00857513006513US DIAGNOSTICS18-57513-00651-32023-07-17
00857513006520US DIAGNOSTICS18-57513-00652-02023-07-17
00857513006537US DIAGNOSTICS18-57513-00653-72023-07-17
00857513006490US DIAGNOSTICS18-57513-00649-02023-07-11
M992CTIS2911CareTouch1CTIS2912023-02-07
M99230222818UPC3MedtLancet I130-22-2818-UPC2026-03-31
M992SSINS0131083SYRINGE SOLUTIONS1SS-INS-01-31082026-03-16
M99230403160120LCH3LCH130-40-3160-120LCH2026-03-04
M992INS01U10031080Medtpoint1INS-01-U100-31082026-02-09
M99230403180150LCH3LCH130-40-3180-150LCH2025-09-26
M99208013103P120LCH3LCH108-01-3103P-120LCH2025-06-23
M99230403150UPC3Medtfine130-40-3150-UPC2025-03-24

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Primary DI, Brand, Company table
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