AccessGUDID - DEVICE: GLUCO-CARE Insulin Syringes (00810008216477)

GUDID

Device Identifier (DI) Information

Brand Name: GLUCO-CARE Insulin Syringes
Version or Model: GLUCO-CARE Insulin Syringes 0.3ml/cc, 31g x 5/16"(8mm), U-100, 10/bg x 10,100/bx
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2241
Company Name: MediVena, LLC

Primary DI Number: 00810008216477
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080740980 *Terms of Use

Device Description: The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.

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?
38501	Insulin syringe/needle, basic	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

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
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 31 Gauge
Total Volume: 0.3 Milliliter
Length: 8 Millimeter

Device Record Status

Public Device Record Key: 4c2892cc-065a-45ca-b3ce-d255bbc58eaf
Public Version Date: February 24, 2025
Public Version Number: 1
DI Record Publish Date: February 15, 2025