FDA.reportPublic FDA data

CAREFINE

Primary DI
00894743001710
Brand
CAREFINE
Company
FACET TECHNOLOGIES, LLC
Model
1100003
Device description
CareFine Pen Needles - 6mm x 31G (3 bevel)
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
20894743001714PackageGS130In Commercial Distribution
00894743001710PrimaryGS10
10894743001717Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089474300171420894743001714
00894743001710008947430017108947430017100894743001710
1089474300171710894743001717

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter
Needle Gauge31Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130518376
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830006705NeatNickPreemie203008P2026-06-01
00382830006712NeatNickFull Term203008FT2026-06-01
00894743001338Facet Medical Technologies010800101080012020-09-26
00894743001345Facet Medical Technologies010800201080022020-09-26
00894743001369Facet Medical Technologies011000101100012020-04-29
00894743001376Facet Medcial Technologies011000201100022020-04-29
00894743001017SureSealLarge851002019-07-02
00894743001024SureSealExtra Large852002019-07-02
00894743001000CAREFINE11000312017-03-10
00894743001147CAREFINE11000392017-03-10
00894743001703CAREFINE11000002017-03-10
00894743001727CAREFINE11000072017-03-10
00894743001734CAREFINE11000152017-03-10
00894743001741CAREFINE11000132017-03-10
00894743001758CAREFINE11000172017-03-10
00894743001765CAREFINE11000332017-03-10
00894743001772CAREFINE11000292017-03-10
00894743001789CAREFINE11000272017-03-10
00894743001796CAREFINE11000412017-03-10
00894743001802CAREFINE11000372017-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26
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00301691863500NOVOFINE PLUS 29GNOVO NORDISK INC.FMI2026-07-31
00301691863906NovoFine® Plus 29GNOVO NORDISK INC.FMI2026-07-31
10192253005066MonojectCardinal Health 200, LLCFMI2026-07-31
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00810094578053Curaplex®BOUND TREE MEDICAL, LLCFMI2026-07-30
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