FDA.reportPublic FDA data

Red Tunica

Primary DI
00850036464488
Brand
Red Tunica
Company
Rodimedi & Associates, Inc.
Model
RT-37312
Catalog number
RT-37312
Device description
Disposable Insulin Syringe With Needle For Single Use - 31G 0.5mL 8mm - 100 Pcs Box // 10 Bags of 10 Pcs
Published
2024-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K151949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151949000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850036464485PackageGS15In Commercial Distribution
00850036464488PrimaryGS10
00850036464471Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003646448510850036464485
00850036464488008500364644888500364644880850036464488
00850036464471008500364644718500364644710850036464471

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
Length8Millimeter
Needle Gauge31Gauge
Total Volume0.5Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1 (888) 315-9472jrodriguez@rodimedi.com

Regulatory Flags#

DUNS number
785417726
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
00810160810377Red TunicaRT-20134RT-201342025-03-14
00810160810414Red TunicaRT-20130RT-201302025-03-14
00850036464662Red TunicaRT-20132RT-201322025-03-14
00810160810360Red TunicaRT-20134RT-201342025-03-14
10810160810411Red TunicaRT-20130RT-201302025-03-14
20850036464666Red TunicaRT-20132RT-201322025-03-14
00810160810001Red TunicaRT-34145RT-341452024-06-14
00810160810032Red TunicaRT-34148RT-341482024-06-14
00810160810063Red TunicaRT-34151RT-341512024-06-14
00810160810094Red TunicaRT-34154RT-341542024-06-14
00810160810124Red TunicaRT-34157RT-341572024-06-14
00810160810155Red TunicaRT-34163RT-341632024-06-14
00850036464808Red TunicaRT-34166RT-341662024-06-14
00810160810018Red TunicaRT-34145RT-341452024-06-14
00810160810049Red TunicaRT-34148RT-341482024-06-14
00810160810070Red TunicaRT-34151RT-341512024-06-14
00810160810100Red TunicaRT-34154RT-341542024-06-14
00810160810131Red TunicaRT-34157RT-341572024-06-14
00810160810162Red TunicaRT-34163RT-341632024-06-14
00850036464815Red TunicaRT-34166RT-341662024-06-14

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