FDA.reportPublic FDA data

Polycarbonate syringe -

Primary DI
05391530753593
Brand
Polycarbonate syringe -
Company
DMC MEDICAL LIMITED
Model
FD-1054NS - 10ml PC Syringe - Nitro Print - Red P
Catalog number
FD-1054NS - 10ml PC Syringe - Nitro Print - Red P
Published
2026-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05391530753593PrimaryGS10
05391530752961Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530753593053915307535935391530753593
05391530752961053915307529615391530752961

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
05391530754941NuGen syringeFD-1180NS 3ml Nugen Syringe - Red PlungerFD-1180NS 3ml Nugen Syringe - Red Plunger2026-06-03
05391530754965NuGen syringeFD-1162NS 10ml Nugen Syringe - Red PlungerFD-1162NS 10ml Nugen Syringe - Red Plunger2026-06-03
05391530753814NuGen syringeFD-1036NS - 30ml PC Syringe - Blue PlungerFD-1036NS - 30ml PC Syringe - Blue Plunger2026-06-01
05391530753876NuGen syringeFD-1159NS - 1ml Nugen Syringe - White PlungerFD-1159NS - 1ml Nugen Syringe - White Plunger2026-06-01
05391530753890NuGen syringeFD-1172NS - 1ml Nugen Syringe - Blue PlungerFD-1172NS - 1ml Nugen Syringe - Blue Plunger2026-06-01
05391530753913NuGen syringeFD-1165NS - 10ml Nugen Syringe - Purple PlungerFD-1165NS - 10ml Nugen Syringe - Purple Plunger2026-06-01
05391530753852NuGen syringeFD-1167NS 3ml Nugen Syringe - Blue PlungerFD-1167NS 3ml Nugen Syringe - Blue Plunger2026-05-31
05391530753944Polycarbonate syringeFD-1017NS -1ml PC Syringe White PlungerFD-1017NS -1ml PC Syringe White Plunger2026-06-03
05391530753951Polycarbonate syringeFD-1018NS - 1ml PC Syringe - Blue SyringeFD-1018NS - 1ml PC Syringe - Blue Syringe2026-06-03
05391530754217Polycarbonate syringeFD-1078NS 20ml PC Syringe - White Plunger - SalineFD-1078NS 20ml PC Syringe - White Plunger - Saline2026-06-03
05391530754620Polycarbonate syringeFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699Polycarbonate syringeFD-1075NS 10ml PC Syringe - Light Blue Plunger XylFD-1075NS 10ml PC Syringe - Light Blue Plunger Xyl2026-06-03
05391530753968Polycarbonate syringeFD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC Syringe - Yellow Plunger2026-06-02
05391530754088Polycarbonate syringeFD-1021NS 3ml PC Syringe - White PlungerFD-1021NS 3ml PC Syringe - White Plunger2026-06-02
05391530754194Polycarbonate syringeFD-1034NS 20ml PC Syringe - Red PlungerFD-1034NS 20ml PC Syringe - Red Plunger2026-06-02
05391530754224Polycarbonate syringeFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231Polycarbonate syringeFD-1092NS 20ml PC Syringe Heparin Print - Red PlunFD-1092NS 20ml PC Syringe Heparin Print - Red Plun2026-06-02
05391530753456Polycarbonate syringeFD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NS - 20ml PC Syringe Blue Plunger2026-06-01
05391530753463Polycarbonate syringeFD-1031NS - White PlungerFD-1031NS - 20ml PC Syringe White Plunger2026-06-01
05391530753487Polycarbonate syringeFD-1113NS - 10ml PC Syringe Contrast Dark Green PlFD-1113NS - 10ml PC Syringe Contrast Dark Green Pl2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01