FDA.reportPublic FDA data

CareLiving Safety lancet 28G

Primary DI
00383568100215
Brand
CareLiving Safety lancet 28G
Company
Care Living Diagnostics Inc.
Model
Safety Lancet 28
Catalog number
83568-1002-15
Device description
Safety lancet 28G*1.8mm,100 Sterile Tip Lancets Per Box,One Handed Use,No Lancing Device Required,Automic Needle Retraction,Lock out after use is a Safety Feature That Negates Needle stick injuries And Prevents Blood cross-contamination
Published
2023-11-10
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383568100212PackageGS1100Not in Commercial Distribution
00383568100215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038356810021210383568100212
00383568100215003835681002153835681002150383568100215

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge28Gauge

Regulatory Flags#

DUNS number
125354643
Device count
1
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