AccessGUDID - DEVICE: GLUCO-CARE Safety Lancets 28G x 1.8mm (00810008214374)

GUDID

Device Identifier (DI) Information

Brand Name: GLUCO-CARE Safety Lancets 28G x 1.8mm
Version or Model: GLUCO-CARE Safety Lancets 28G x 1.8mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MediVena, LLC

Primary DI Number: 00810008214374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080740980 *Terms of Use

Device Description: MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. GLUCO-CARE Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap, then pull it out, STEP 2 Press the color-coded main housing to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container.

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 [?]
Premarket Submission Number Not Available/Not Released

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: 92a6d625-0d62-4304-a761-0187648d8c27
Public Version Date: March 05, 2024
Public Version Number: 1
DI Record Publish Date: February 26, 2024