FDA.reportPublic FDA data

EasyLife Insulin syringe 31G 5/16" 1cc 100pcs

Primary DI
10383568400329
Brand
EasyLife Insulin syringe 31G 5/16" 1cc 100pcs
Company
Care Living Diagnostics Inc.
Model
EL-SY03
Catalog number
83568-4003-22
Device description
EasyLife Insulin syringe 31G 5/16" 1cc 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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152808000U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.2016-03-25MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383568400329PackageGS120Not in Commercial Distribution
00383568400322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038356840032910383568400329
00383568400322003835684003223835684003220383568400322

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. 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
10383568300445EasyLife Safety Pen Needles 4MM 31G 100pcsEL340483568-3004-482025-09-18
10383568300452EasyLife Safety Pen Needles 5MM 31G 100pcsEL340583568-3004-552025-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01