FDA.reportPublic FDA data

FD-1039NS - 10ml PC Syringe - Heparin Print - Red Plunger

Primary DI
05391530753609
Brand
FD-1039NS - 10ml PC Syringe - Heparin Print - Red Plunger
Company
DMC MEDICAL LIMITED
Model
FD-1039NS - 10ml PC Syringe
Catalog number
FD-1039NS - 10ml PC Syringe
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K103736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103736000DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGEDmc Medical, Ltd.2011-06-10FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530753609PrimaryGS10
05391530752756Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530753609053915307536095391530753609
05391530752756053915307527565391530752756

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, reusableA non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); it is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment of the female connector (hub) of a hypodermic needle or an administration set. It is typically made of glass and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a reusable device intended to be sterilized prior to use.

Regulatory Flags#

DUNS number
989772017
Device count
800
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
false
Expiration date on label
false
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
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
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerFD-1049NS - 10ml PC SyringeFD-1049NS - 10ml PC Syringe2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerFD-1029NS - 10ml PC SyringeFD-1029NS - 10ml PC Syringe2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerFD-1054NS - 10ml PC SyringeFD-1054NS - 10ml PC Syringe2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerFD-1071NS - 10ml PC SyringeFD-1071NS - 10ml PC Syringe2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerFD-1028NS - 10ml PC SyringeFD-1028NS - 10ml PC Syringe2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerFD-1072NS - 10ml PC SyringeFD-1072NS - 10ml PC Syringe2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerFD-1030NS - 10ml PC SyringeFD-1030NS - 10ml PC Syringe2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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
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
05391530753685FD-1045NS - 10ml PC Syringe - Contrast Print - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753692FD-1046NS - 10ml PC Syringe Contrast Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753708FD-1047NS - 10ml PC Syringe - Lidocaine Print - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753715FD-1103NS - 20ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753722FD-1027NS - 10ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753753FD-1067NS - 3ml PC Syringe - Nitro Print - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753760FD-1038NS - 10ml PC Syringe Heparin Print Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753777FD-1069NS - 6ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01