FDA.reportPublic FDA data

Medt

Primary DI
M992083130031P1
Brand
Medt
Company
Carelife (usa) Inc.
Model
1
Catalog number
08-31-30031P
Device description
"Insulin Syringe 0.3ml 30g 5/16"" Freedom"
Published
2017-04-27
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M992083130031P3PackageHIBCC10In Commercial Distribution
M992083130031P5PackageHIBCC5In Commercial Distribution
M992083130031P1PrimaryHIBCC0
M992083130031P0Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065756949
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
M992CTIS2811CareTouch1CTIS2812023-02-07
M992CTIS3011CareTouch1CTIS3012023-02-07
M992CTIS3051CareTouch1CTIS3052023-02-07
M992CTIS3111CareTouch1CTIS3112023-02-07
M992CTIS3131CareTouch1CTIS3132023-02-07
M992CTIS3151CareTouch1CTIS3152023-02-07
00857513006483US DIAGNOSTICS18-57513-00648-32023-07-17
00857513006506US DIAGNOSTICS18-57513-00650-62023-07-17
00857513006513US DIAGNOSTICS18-57513-00651-32023-07-17
00857513006520US DIAGNOSTICS18-57513-00652-02023-07-17
00857513006537US DIAGNOSTICS18-57513-00653-72023-07-17
00857513006490US DIAGNOSTICS18-57513-00649-02023-07-11
M992CTIS2911CareTouch1CTIS2912023-02-07
M99230222818UPC3MedtLancet I130-22-2818-UPC2026-03-31
M992SSINS0131083SYRINGE SOLUTIONS1SS-INS-01-31082026-03-16
M99230403160120LCH3LCH130-40-3160-120LCH2026-03-04
M992INS01U10031080Medtpoint1INS-01-U100-31082026-02-09
M99230403180150LCH3LCH130-40-3180-150LCH2025-09-26
M99208013103P120LCH3LCH108-01-3103P-120LCH2025-06-23
M99230403150UPC3Medtfine130-40-3150-UPC2025-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
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