AccessGUDID - DEVICE: TechLITE Insulin Syringes 1mL 31G x 5/16" (8mm) (00015482613136)

GUDID

Device Identifier (DI) Information

Brand Name: TechLITE Insulin Syringes 1mL 31G x 5/16" (8mm)
Version or Model: 260313
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARKRAY USA, INC.

Primary DI Number: 00015482613136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 008171162 *Terms of Use

Device Description: TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.

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":	No
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.0 Milliliter
Length: 8 Millimeter
Needle Gauge: 31 Gauge

Device Record Status

Public Device Record Key: 72d6b9a5-9237-4e5a-8db7-6e924a819366
Public Version Date: November 06, 2023
Public Version Number: 5
DI Record Publish Date: January 09, 2018