ONE-CARE Safety Lancets 1103

GUDID 00810008210116

ONE-CARE Safety Lancets 26G x 1.8mm, LowFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure.

MediVena, LLC

Manual blood lancing device, single-use
Primary Device ID00810008210116
NIH Device Record Key4a8fbf21-1064-47d1-9410-7bf17c3fe643
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE Safety Lancets
Version Model Number1103 ONE-CARE Safety Lancets 26G x 1.8mm, LowFlow,
Catalog Number1103
Company DUNS080740980
Company NameMediVena, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com

Device Dimensions

Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter
Needle Gauge26 Gauge
Length1.8 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008210109 [Primary]
GS100810008210116 [Package]
Contains: 00810008210109
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-24
Device Publish Date2025-02-16

On-Brand Devices [ONE-CARE Safety Lancets]

00810008211595ONE-CARE Safety Lancets 21G x 1.8mm, LowFlow, are sterile, single-use devices designed for capil
00810008210390ONE-CARE Safety Lancets 18G x 1.8mm, MaxFlow, are sterile, single-use devices designed for capil
00810008210130ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, are sterile, single-use devices designed for ca
00810008210116ONE-CARE Safety Lancets 26G x 1.8mm, LowFlow, are sterile, single-use devices designed for capil
00810008210093ONE-CARE Safety Lancets 28G x 1.8mm, MiniFlow, are sterile, single-use devices designed for capi
00810008210079ONE-CARE Safety Lancets 30G x 1.5mm, MicroFlow, are sterile, single-use devices designed for cap

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