FDA.reportPublic FDA data

Medpoint

Primary DI
M99208012905S5
Brand
Medpoint
Company
Carelife (usa) Inc.
Model
1
Catalog number
08-01-2905S
Device description
Safety insulin syringe 1ML 29Gx1/2"
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191639000TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.2020-09-11MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M99208012905S5PackageHIBCC5In Commercial Distribution
M99208012905S3PrimaryHIBCC0
M99208012905S0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7709356499li@carelifeusa.com

Regulatory Flags#

DUNS number
065756949
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08056999020248SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
08056999020255SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
08056999020262SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
10840330704868ProCureTwin Med, LLCMEG2026-05-27
10840330704875ProCureTwin Med, LLCMEG2026-05-27
10840330705544ProCureTwin Med, LLCMEG2026-05-27
10840330705551ProCureTwin Med, LLCMEG2026-05-27
10840330705568ProCureTwin Med, LLCMEG2026-05-27
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
09347144013093Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
10850053289627SURGYCOSurgyco LLCMEG2024-08-09
10850053289634SURGYCOSurgyco LLCMEG2024-08-09
10850053289641SURGYCOSurgyco LLCMEG2024-08-09
10850053289665SURGYCOSurgyco LLCMEG2024-08-09
10885380184703MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184987MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184994MonojectCardinal Health 200, LLCMEG2024-03-26
10193489037869MedlineMEDLINE INDUSTRIES, INC.MEG2024-02-01
10612479268705McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10612479268736McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10193489037814MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037821MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037838MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037845MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037852MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037890MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037906MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10