FDA.reportPublic FDA data

ONE-CARE Safety Lancets

Primary DI
00810008210147
Brand
ONE-CARE Safety Lancets
Company
MediVena, LLC
Model
1106 ONE-CARE Safety Lancets 21G x 2.4mm, ExtraFlo
Catalog number
1106
Device description
ONE-CARE Safety Lancets 21G x 2.4mm, LowFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure.
Published
2025-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222376000Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co. , Ltd.2022-10-03FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008210154PackageGS120In Commercial Distribution
00810008210147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008210154008100082101548100082101540810008210154
00810008210147008100082101478100082101470810008210147

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.4Millimeter
Needle Gauge21Gauge

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
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
00810008215593ONE-CARE Insulin Syringes "2272 ONE-CARE Insulin Syringes 0.3ml/cc, 30G x 5/22722025-10-14

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Primary DI, Brand, Company table
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