AccessGUDID - DEVICE: ONE-CARE TB Safety Syringes (00810008214107)

GUDID

Device Identifier (DI) Information

Brand Name: ONE-CARE TB Safety Syringes
Version or Model: ONE-CARE TB Safety Syringes, 1mL, 28G x 0.5’’
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2107
Company Name: MediVena, LLC

Primary DI Number: 00810008214107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080740980 *Terms of Use

Device Description: ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of dosing.

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):	No
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?
45042	Metered-delivery hypodermic syringe/needle	A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEG	Syringe, Antistick

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150758	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
Total Volume: 1 Milliliter
Needle Gauge: 28 Gauge
Length: 0.5 Inch

Device Record Status

Public Device Record Key: f323f77b-4630-4f25-8d93-876cc556f684
Public Version Date: October 31, 2023
Public Version Number: 1
DI Record Publish Date: October 23, 2023