FDA.reportPublic FDA data

1ml Insulin Suresafe Syringe

Primary DI
05391530750158
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
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.

Regulatory Flags#

DUNS number
989772017
Device count
1
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
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerFD-1017NS -1ml PC SyringeFD-1017NS -1ml PC Syringe2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerFD-1018NS - 1ml PC SyringeFD-1018NS - 1ml PC Syringe2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintFD-1078NS 20ml PC SyringeFD-1078NS 20ml PC Syringe2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineFD-1075NS 10ml PC SyringeFD-1075NS 10ml PC Syringe2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeFD-1180NS 3ml Nugen SyringeFD-1180NS 3ml Nugen Syringe2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerFD-1162NS 10ml Nugen SyringeFD-1162NS 10ml Nugen Syringe2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC SyringeFD-1019NS - 1ml PC Syringe2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerFD-1021NS 3ml PC SyringeFD-1021NS 3ml PC Syringe2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerFD-1034NS 20ml PC SyringeFD-1034NS 20ml PC Syringe2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerFD-1092NS 20ml PC SyringeFD-1092NS 20ml PC Syringe2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NSFD-1032NS2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerFD-1031NSFD-1031NS2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerFD-1113NS - 10ml PC SyringeFD-1113NS - 10ml PC Syringe2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintFD-1051NS - 10ml PC SyringeFD-1051NS - 10ml PC Syringe2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerFD-1043NS - 10ml PC SyringeFD-1043NS - 10ml PC Syringe2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerFD-1107NS - 30ml PC SyringeFD-1107NS - 30ml PC Syringe2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerFD-1026NS - 10ml PC SyringeFD-1026NS - 10ml PC Syringe2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerFD-1158NS - 10ml PC SyringeFD-1158NS - 10ml PC Syringe2026-06-01

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