FDA.reportPublic FDA data

CareLiving Push Button Activated Safety lancet 28G

Primary DI
00383568100239
Brand
CareLiving Push Button Activated Safety lancet 28G
Company
Care Living Diagnostics Inc.
Model
Push Button Activated Safety Lancet 28
Catalog number
83568-1002-39
Device description
Push Button Activated Safety lancet 28G*1.6mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and low puncture force provide users an almost painless experience of blood sampling.The Lancet is used for perpheral blood collection when clinical examination.
Published
2024-01-25
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

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383568100239PrimaryGS10
10383568100236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383568100239003835681002393835681002390383568100239
1038356810023610383568100236

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge28Gauge

Regulatory Flags#

DUNS number
125354643
Device count
100
Kit
true
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
00383568100819CareLiving Blood Glucose Test Strips 100ctCL-10083568-1008-192023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct CL-5083568-1008-572023-11-15
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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
10383568300445EasyLife Safety Pen Needles 4MM 31G 100pcsEL340483568-3004-482025-09-18
10383568300452EasyLife Safety Pen Needles 5MM 31G 100pcsEL340583568-3004-552025-09-18

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