FDA.reportPublic FDA data

ONE-CARE Luer-Lock Syringes

Primary DI
00810008215449
Brand
ONE-CARE Luer-Lock Syringes
Company
MediVena, LLC
Model
ONE-CARE Luer-Lock Syringes 20ml
Catalog number
2007
Device description
The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.
Published
2025-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008215449PackageGS1100In Commercial Distribution
00810008218907PackageGS16In Commercial Distribution
00810008215432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008215449008100082154498100082154490810008215449
00810008218907008100082189078100082189070810008218907
00810008215432008100082154328100082154320810008215432

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume20Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4045142586info@medivena.com

Regulatory Flags#

DUNS number
080740980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
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
00810008218563ONE-CARE Insulin Syringes 2296 ONE-CARE Insulin Syringes 1ml 30Gx12.7mm, Bl22962025-10-15
00810008214435ONE-CARE Insulin Syringes "2271 ONE-CARE Insulin Syringes 0.3ml/cc, 31g x 5/22712025-10-14

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Primary DI, Brand, Company table
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