FDA.reportPublic FDA data

ONE-CARE PLUS Safety Lancets

Primary DI
00810008210345
Brand
ONE-CARE PLUS Safety Lancets
Company
MediVena, LLC
Model
1002 ONE-CARE PLUS Safety Lancets 28G x 1.8mm, Min
Catalog number
1002
Device description
Contact-activated ONE-CARE PLUS Safety Lancets 28G x 1.8 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience.
Published
2025-02-16
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
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
K222408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222408000Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd.2022-11-29FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008210345PackageGS120In Commercial Distribution
00810008210185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008210345008100082103458100082103450810008210345
00810008210185008100082101858100082101850810008210185

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
Length1.8Millimeter
Needle Gauge28Gauge

Storage And Handling#

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

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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