FDA.reportPublic FDA data

ONE-CARE Insulin Safety Syringes

Primary DI
10810008210021
Brand
ONE-CARE Insulin Safety Syringes
Company
MediVena, LLC
Model
ONE-CARE Insulin Safety Syringe, 0.5mL, 29G x 0.5
Catalog number
2102
Device description
ONE-CARE® Insulin Safety Syringes are single use devices intended for safe insulin delivery. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of insulin dosing.
Published
2023-10-16
Public version status
New
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
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150758000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008211564PackageGS110In Commercial Distribution
10810008210021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008211564008100082115648100082115640810008211564
1081000821002110810008210021

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Needle Gauge29Gauge
Total Volume0.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
4045142586info@medivena.com

Regulatory Flags#

DUNS number
080740980
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
00810008214565ONE-CARE5015-250 Tube Holders, 250/bg, 4bg/cs5015-2502026-09-11
00810008212301ONE-CARE5016 ONE-CARE Safety Tube Holders,50162026-09-04
00810008211519ONE-CARE Pen Needles,3018-ONE-CARE Pen Needles, 31G x 6mm, Blue, 100ct,30182025-03-12
00810008217221GLUCO-CARE PLUS Pen Needles3026-GLUCO-CARE PLUS Pen Needles, 31G x 5mm, Purpl30262025-11-11
00810008210147ONE-CARE Safety Lancets1106 ONE-CARE Safety Lancets 21G x 2.4mm, ExtraFlo11062025-10-23
00810008211502ONE-CARE Pen Needles3017-ONE-CARE Pen Needles, 31G x 5mm, Purple, 100c30172025-10-20
00810008214015ONE-CARE Pen Needles3011-ONE-CARE Pen Needles 33G x 4mm, Pink, 100/bx,30112025-10-20
00810008214275ONE-CARE Pen Needles3016-ONE-CARE Pen Needles 31G x 4mm, Sky Blue, 10030162025-10-20
00810008215654ONE-CARE Insulin Syringes "2274 ONE-CARE Insulin Syringes 1ml/cc, 31g x 5/1622742025-10-15
00810008215685ONE-CARE Insulin Syringes "2275 ONE-CARE Insulin Syringes 1ml/cc, 30G x 5/1622752025-10-15
00810008215715ONE-CARE Insulin Syringes "2276 ONE-CARE Insulin Syringes 1ml/cc, 30G x 1/2"22762025-10-15
00810008215746ONE-CARE Insulin Syringes "2278 ONE-CARE Insulin Syringes 1ml/cc, 27G x 1/2"22782025-10-15
00810008216507ONE-CARE Insulin Syringes "2277 ONE-CARE Insulin Syringes 1ml/cc, 29G x 1/2"22772025-10-15
00810008217429ONE-CARE Insulin Syringes 2288 ONE-CARE Insulin Syringes 0.3ml 31Gx6mm, Blis22882025-10-15
00810008218259ONE-CARE Insulin Syringes 2291 ONE-CARE Insulin Syringes 0.3ml 31Gx8mm, Bli22912025-10-15
00810008218419ONE-CARE Insulin Syringes 2290 ONE-CARE Insulin Syringes 1ml 31Gx6mm, Blist22902025-10-15
00810008218440ONE-CARE Insulin Syringes 2292 ONE-CARE Insulin Syringes 0.5ml 31Gx8mm, Bli22922025-10-15
00810008218471ONE-CARE Insulin Syringes 2293 ONE-CARE Insulin Syringes 1ml 31Gx8mm, Blist22932025-10-15
00810008218501ONE-CARE Insulin Syringes 2294 ONE-CARE Insulin Syringes 0.3ml 30Gx12.7mm, B22942025-10-15
00810008218532ONE-CARE Insulin Syringes 2295 ONE-CARE Insulin Syringes 0.5ml 30Gx12.7mm, 22952025-10-15

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