AccessGUDID - DEVICE: ONE-CARE PLUS Safety Lancets (00810008210185)

GUDID

Device Identifier (DI) Information

Brand Name: ONE-CARE PLUS Safety Lancets
Version or Model: 1002 ONE-CARE PLUS Safety Lancets 28G x 1.8mm, MiniFlow, Pink, 100/bx, 20bx/cs
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1002
Company Name: MediVena, LLC

Primary DI Number: 00810008210185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080740980 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61578	Manual blood lancing device, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222408	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 28 Gauge
Length: 1.8 Millimeter

Device Record Status

Public Device Record Key: 5094b37f-aae0-4666-a9ab-b2697a2e9bb3
Public Version Date: February 24, 2025
Public Version Number: 1
DI Record Publish Date: February 16, 2025