FDA.reportPublic FDA data

Publix Insulin Syringe

Primary DI
10041415087788
Brand
Publix Insulin Syringe
Company
PUBLIX SUPER MARKETS, INC.
Model
252353
Device description
Publix 6mm 31G 3/10mL Insulin Syringe Box
Published
2019-01-01
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062702000ULTICARE DISPOSABLE SYRINGES AND NEEDLESUltimed, Inc.2006-11-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20041415083787PackageGS110In Commercial Distribution
30041415083784PackageGS15In Commercial Distribution
10041415087788PrimaryGS10
00041415087781Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004141508378720041415083787
3004141508378430041415083784
1004141508778810041415087788
00041415087781000414150877810414150877810041415087781

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Regulatory Flags#

DUNS number
006922009
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041415034747Publix9479022019-10-14
00041415318731PUBLIX84-35884-3582016-09-23
00041415319738PUBLIX84-3592016-09-24
00041415426733PUBLIX84-3752016-09-24
20041415101788Publix 3225452025-03-03
30041415017857Publix 3225452025-03-03
00041415055759PUBLIX Personal Lubricant7W92019-10-16
20041415100781Publix 6mm 32G PN3175702024-07-15
30041415100788Publix 6mm 32G PN3175702024-07-15
20041415098781Publix UltiGuard2998192024-07-01
20041415099788Publix UltiGuard2999262024-07-01
30041415098788Publix UltiGuard2998192024-07-01
30041415099785Publix UltiGuard2999262024-07-01
20041415318735PUBLIX84-35884-3582016-09-23
20041415319732PUBLIX84-3592016-09-24
20041415426737PUBLIX84-3752016-09-24
00041415095786PublixBP3GX1-4BPBX2023-08-10
00041415096769PublixOne Step Pregnancy Test2020-01-28
00041415024762Publix One Step Pregnancy TestFPPL2016-08-10
00041415031784Publix AutoletAT 0274PX2023-06-23

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MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
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00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04