FDA.reportPublic FDA data

1ml Insulin Suresafe Syringe

Primary DI
05391530750172
Brand
1ml Insulin Suresafe Syringe
Company
DMC MEDICAL LIMITED
Model
1ml Insulin Syringe - 29G x 1/2"
Catalog number
FD-SSFX01L-29
Device description
1ml Insulin Automatic Retractable Syringe - 29G x 1/2" - Sterile
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141349000Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd.2015-04-10MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750165PackageGS1100In Commercial Distribution
05391530750172PackageGS121In Commercial Distribution
05391530750158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750165053915307501655391530750165
05391530750172053915307501725391530750172
05391530750158053915307501585391530750158

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
989772017
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
05391530753982polycarbonate syringesFD-1095NS - 1ml PC Syringe Dark Green Plunger 1ml FD-1095NS - 1ml PC Syringe Dark Green Plunger 1ml 2026-10-01
05391530753999polycarbonate syringesFD-1094NS - 1ml PC Syringe Light Green Plunger 1mlFD-1094NS - 1ml PC Syringe Light Green Plunger 1ml2026-10-01
05391530754408polycarbonate syringesFD-1076NS 10ml PC Syringe Light Blue Flush PrintFD-1076NS 10ml PC Syringe Light Blue Flush Print2026-10-01
05391530754439polycarbonate syringes10ml PC Syringe Light Blue Plunger Saline Print10ml PC Syringe Light Blue Plunger Saline Print2026-10-01
05391530754750polycarbonate syringesFD-1116NS 10ml PC Syringe White Plunger Nitro PrinFD-1116NS 10ml PC Syringe White Plunger Nitro Prin2026-10-01
05391530754798polycarbonate syringesFD-1120NS 10ml PC Syringe Light Green Plunger SaliFD-1120NS 10ml PC Syringe Light Green Plunger Sali2026-10-01
05391530755351polycarbonate syringesFD-1190NS 10ml Nugen Syringe Yellow Plunger Non-StFD-1190NS 10ml Nugen Syringe Yellow Plunger Non-St2026-10-01
05391530754033Polycarbonate SyringeFD-1098NS 3ml PC Syringe Dark Green PlungerFD-1098NS 3ml PC Syringe Dark Green Plunger2026-09-27
05391530754057Polycarbonate SyringeFD-1097NS 3ml PC Syringe Light Green PlungerFD-1097NS 3ml PC Syringe Light Green Plunger2026-09-27
05391530754118Polycarbonate SyringeFD-1068NS 3ml PC Syringe Red Plunger Nitro PrintFD-1068NS 3ml PC Syringe Red Plunger Nitro Print2026-09-27
05391530754149polycarbonate syringe6ml PC Syringe Light Green Plunger - Non-Sterile6ml PC Syringe Light Green Plunger - Non-Sterile2026-09-27
05391530754170polycarbonate syringeFD-1099NS 6ml PC Syringe Yellow PlungerFD-1099NS 6ml PC Syringe Yellow Plunger2026-09-27
05391530754255polycarbonate syringeFD-1105NS 20ml PC Syringe with Dark Green PlungerFD-1105NS 20ml PC Syringe with Dark Green Plunger2026-09-27
05391530754279polycarbonate syringe20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 2026-09-27
05391530754286polycarbonate syringeFD-1104NS 20ml PC Syringe with Light Green PlungerFD-1104NS 20ml PC Syringe with Light Green Plunger2026-09-27
05391530754323polycarbonate syringe30ml PC Syringe White Plunger30ml PC Syringe White Plunger2026-09-27
05391530754385polycarbonate syringesFD-1079NS 10ml PC Syringe Purple Plunger Heparin PFD-1079NS 10ml PC Syringe Purple Plunger Heparin P2026-09-27
05391530754415polycarbonate syringeFD-1037NS 10ml PC Syringe Light Blue Plunger HeparFD-1037NS 10ml PC Syringe Light Blue Plunger Hepar2026-09-27
05391530754477polycarbonate syringeFD-1041NS 10ml PC Syringe Light Green Plunger HepaFD-1041NS 10ml PC Syringe Light Green Plunger Hepa2026-09-27
05391530754484polycarbonate syringe10ml PC Syringe Light Green Plunger Lidocaine Prin10ml PC Syringe Light Green Plunger Lidocaine Prin2026-09-27

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Primary DI, Brand, Company table
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