FDA.reportPublic FDA data

EasyLife Safety Pen Needles 4MM 31G 100pcs

Primary DI
10383568300445
Brand
EasyLife Safety Pen Needles 4MM 31G 100pcs
Company
Care Living Diagnostics Inc.
Model
EL3404
Catalog number
83568-3004-48
Device description
EasyLife Safety Pen Needles 4MM 31G 100pcs
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10383568300445PackageGS150In Commercial Distribution
00383568300448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038356830044510383568300445
00383568300448003835683004483835683004480383568300448

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125354643
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383568100819CareLiving Blood Glucose Test Strips 100ctCL-10083568-1008-192023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct CL-5083568-1008-572023-11-15
00383568101618EZflex Lidocaine 4% pain relief patch 5 count112025-11-04
00383568101625EZflex Lidocaine 4% & Menthol 1% pain relief patch 5 count112025-11-04
00383568300448EasyLife Safety Pen Needles 4MM 31G 100pcsEL340483568-3004-482025-09-18
00383568300455EasyLife Safety Pen Needles 5MM 31G 100pcsEL340583568-3004-552025-09-18
00383568400247EasyLife Mini Safety Pen Needles 4MM 31G 100pcsEL420483568-4002-472025-09-18
00383568400315EasyLife Insulin syringe 30G 1/2” 1cc 100pcsEL-SY0183568-4003-152025-09-18
00383568400322"EasyLife Insulin syringe 31G 5/16"" 1cc 100pcs"EL-SY0383568-4003-222025-09-18
00383568400339"EasyLife Insulin syringe 30G 5/16"" 1cc 100pcs"EL-SY0283568-4003-392025-09-18
00383568400421"EasyLife safety Insulin syringe 29G 1/2"" 1ml/cc 100pcs"EL-SY0483568-4004-212025-09-18
00383568400438EasyLife safety Insulin syringe 30G 1/2” 1/2ml/cc 100pcsEL-SY0583568-4004-382025-09-18
00383568400445"EasyLife safety Insulin syringe 30G 5/16"" 1/2ml/cc 100pcs"EL-SY0783568-4004-452025-09-18
00383568400452EasyLife safety Insulin syringe 30G 1/2” 1ml/cc 100pcsEL-SY0683568-4004-522025-09-18
00383568400469"EasyLife safety Insulin syringe 30G 5/16"" 1ml/cc 100pcs"EL-SY0883568-4004-692025-09-18
00383568400476"EasyLife safety Insulin syringe 31G 5/16"" 1/2ml/cc 100pcs"EL-SY0983568-4004-762025-09-18
00383568400483"EasyLife safety Insulin syringe 31G 5/16"" 1ml/cc 100pcs"EL-SY1083568-4004-832025-09-18
00383568400490"EasyLife safety Insulin syringe 32G 5/16"" 1ml/cc 100pcs"EL-SY1183568-4004-902025-09-18
10383568300452EasyLife Safety Pen Needles 5MM 31G 100pcsEL340583568-3004-552025-09-18
10383568400244EasyLife Mini Safety Pen Needles 4MM 31G 100pcsEL420483568-4002-472025-09-18

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