FDA.reportPublic FDA data

Jelco

Primary DI
10351688041852
Brand
Jelco
Company
ICU MEDICAL, INC.
Model
4139
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K946289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946289000DEVONS POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.1995-07-10FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688041856PackageGS110In Commercial Distribution
10351688041852PrimaryGS10
20351688041859Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035168804185630351688041856
1035168804185210351688041852
2035168804185920351688041859

GMDN Terms#

Term, Definition table
TermDefinition
Needle guardA cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
100
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
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22
10887709204697BivonaFU26IN40NGF160N2026-09-22
10887709204703BivonaFT26IN40NGF162N2026-09-22
10887709204710BivonaFT26IN35NGF161N2026-09-22
10887709204727BivonaFT26IN40NGE166N2026-09-22
10887709204741BivonaFT26IN40NGF160N2026-09-22
10887709204475BivonaHU26IS45NGG042N2026-09-21
10887709204482BivonaSU26IN45NGF043N2026-09-21
10887709204574BivonaSF26IN70SSC152N2026-09-21

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Primary DI, Brand, Company table
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MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
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00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26
06972857295677contour comfort Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCFMI2026-08-13