FDA.reportPublic FDA data

Comfort EZ

Primary DI
00850083784348
Brand
Comfort EZ
Company
S.D.I. USA, INC.
Model
NS18G3ML1.5
Device description
"18G 1.5"" 3mL syringe (Exchangeable Needle) Non-Safety Needle Ultra Thin Wall 100/bx 8bx/cs"
Published
2026-02-13
Public version status
New
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
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083784348PrimaryGS10
20850083784342Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083784348008500837843488500837843480850083784348
2085008378434220850083784342

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch
Needle Gauge18Gauge
Total Volume3Milliliter

Regulatory Flags#

DUNS number
116722847
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083784003Comfort EZLL12026-02-13
00850083784041Comfort EZLL1INS2026-02-13
00850083784058Comfort EZHYP18G12026-02-13
00850083784171Comfort EZHYP25G1S2026-02-13
00850083784270Comfort EZSS23G3ML12026-02-13
00850083784324Comfort EZSSTB25G1ML582026-02-13
00850083784409Comfort EZBLN18G1.52026-02-13
20850083784007Comfort EZLL12026-02-13
20850083784045Comfort EZLL1INS2026-02-13
20850083784052Comfort EZHYP18G12026-02-13
20850083784175Comfort EZHYP25G1S2026-02-13
20850083784274Comfort EZSS23G3ML12026-02-13
20850083784328Comfort EZSSTB25G1ML582026-02-13
20850083784342Comfort EZNS18G3ML1.52026-02-13
20850083784403Comfort EZBLN18G1.52026-02-13
00850002860702Comfort EZ ProSPN-30G850002-0860-702023-08-01
00850002860719Comfort EZ ProSPN-31G550002-0860-712023-08-01
00850002860726Comfort EZ ProSPN-31G450002-0860-722023-08-01
10850002860709Comfort EZ ProSPN-30G850002-0860-702023-08-01
10850002860716Comfort EZ ProSPN-31G550002-0860-712023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
20192253036999MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037125MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037132MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037156MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037194MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037200MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037255MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037262MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037279MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038269MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038283MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038290MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03