FDA.reportPublic FDA data

Jelco

Primary DI
00351688070909
Brand
Jelco
Company
ICU MEDICAL, INC.
Model
402705
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071785000HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGESmiths Medical Asd, Inc.2007-08-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688070906PackageGS1100In Commercial Distribution
30351688070900PackageGS110In Commercial Distribution
00351688070909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035168807090610351688070906
3035168807090030351688070900
00351688070909003516880709093516880709090351688070909

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810011730809huahongTianjin Huahong Technology Co., Ltd.FMI2026-07-10
00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
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
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTractâ„¢RONCADELLE OPERATIONS SRLFMI2026-05-31