FDA.reportPublic FDA data

Red Tunica

Primary DI
00810160810063
Brand
Red Tunica
Company
Rodimedi & Associates, Inc.
Model
RT-34151
Catalog number
RT-34151
Device description
"RedTunica™ Disposable Hypodermic Needle 21G x 1-1/2"" - Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from body parts below the skin's surface."
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172938000Disposable Sterile NeedleJiangsu Caina Medical Co.,Ltd2018-06-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810160810070PackageGS1100In Commercial Distribution
00810160810087PackageGS110000In Commercial Distribution
00810160810063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810160810070008101608100708101608100700810160810070
00810160810087008101608100878101608100870810160810087
00810160810063008101608100638101608100630810160810063

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length38Millimeter
Needle Gauge21Gauge

Contacts#

Phone, Email table
PhoneEmail
+1 (888) 315-9472JRODRIGUEZ@RODIMEDI.COM

Regulatory Flags#

DUNS number
785417726
Device count
1
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
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
00850036464440Red TunicaRT-37297RT-372972024-01-08

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