FDA.reportPublic FDA data

CareTouch

Primary DI
M992CTIS3151
Brand
CareTouch
Company
Carelife (usa) Inc.
Model
1
Catalog number
CTIS315
Device description
"Caretouch U-100 insulin syringe 31g 5/16"" 8mm 0.5cc"
Published
2023-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152808000U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.2016-03-25MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M992CTIS3153PackageHIBCC10In Commercial Distribution
M992CTIS3155PackageHIBCC5In Commercial Distribution
M992CTIS3151PrimaryHIBCC0
M992CTIS3150Unit 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.

Contacts#

Phone, Email table
PhoneEmail
7709356499li@carelifeusa.com

Regulatory Flags#

DUNS number
065756949
Device count
10
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
M99230403180UPC3Medtfine130-40-3180-UPC2025-03-24
M99230403240UPC3Medtfine130-40-3240-UPC2025-03-24
M99208012905P120LCH3Livaclean Health108-01-2905P-120LCH2026-09-30
M99230402912120LCH3Livaclean Health130-40-2912-120LCH2026-09-30
M99230403250120LCH3Livaclean Health130-40-3250-120LCH2026-09-30
M992MTINS01291271MedThermal1MT-INS-01-291272026-09-18
M992MTINS0331081MedThermal1MT-INS-03-31082026-09-18
M99260222818UPC3MedtLite160-22-2818-UPC2026-08-07
M99260223016UPC3MedtLite160-22-3016-UPC2026-08-07
M992CTIS2811CareTouch1CTIS2812023-02-07
M992CTIS3011CareTouch1CTIS3012023-02-07
M992CTIS3051CareTouch1CTIS3052023-02-07
M992CTIS3111CareTouch1CTIS3112023-02-07
M992CTIS3131CareTouch1CTIS3132023-02-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04
00850091070372CoreCareCorecare Products Inc.FMF2026-09-04