FDA.reportPublic FDA data

Kroger Insulin Syringes

Primary DI
00011110375025
Brand
Kroger Insulin Syringes
Company
KROGER CO., THE
Model
032912
Device description
.3cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
10011110375022PackageGS130Not in Commercial Distribution
00011110375025PrimaryGS10
10070030510692Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001111037502210011110375022
00011110375025000111103750250111103750250011110375025
1007003051069210070030510692

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12.7Millimeter
Needle Gauge29Gauge
Total Volume0.3Milliliter

Regulatory Flags#

DUNS number
006999528
Device count
100
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
00041260025747Kroger04126002574763610912025-08-05
00041260011658Kroger PJ Masks0412600116582021-01-13
00041260017957Kroger0412600179572023-01-31
00041260017964Kroger0412600179642023-01-31
00041260377501Kroger0412603775012020-08-17
00041260377518Kroger0412603775182019-10-30
00041260383809Kroger0412603838092020-06-22
00041260383816Kroger0412603838162020-06-22
00041260026850Kroger0412600268502026-03-09
60041260026852Kroger0412600268502026-03-09
60041260025749Kroger04126002574763610912025-08-05
10041260346962Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260346979Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260360685Kroger Premium Blood Glucose Meter8000-067682016-09-24
10041260360692Kroger Premium Blood Glucose Test Strips8000-067622016-09-24
00011110338235Kroger Pen Needles7000013332016-09-24
00041260003592Kroger Pen Needles7000147202019-06-01
00041260003608Kroger Pen Needles7000147212019-06-01
00041260343469Kroger Pen Needles7000013322016-09-24
00041260364624Kroger Pen Needles7000013312016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
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
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01