AccessGUDID - DEVICE: Relion Insulin Syringe, 3/10ml x 6mm (00681131138383)

GUDID

Device Identifier (DI) Information

Brand Name: Relion Insulin Syringe, 3/10ml x 6mm
Version or Model: 328521
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 328521
Company Name: WAL-MART STORES, INC.

Primary DI Number: 00681131138383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: ReliOn Insulin Syringes 3/10mL 31 Gauge, 6mm (15/64") U-100 100count

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 6 Millimeter
Total Volume: 0.3 Milliliter
Needle Gauge: 31 Gauge

Device Record Status

Public Device Record Key: 5762f265-7e06-4028-996a-2a0c006b206f
Public Version Date: February 26, 2024
Public Version Number: 3
DI Record Publish Date: June 12, 2018