AccessGUDID - DEVICE: TRUEplus (00021292005795)

GUDID

Device Identifier (DI) Information

Brand Name: TRUEplus
Version or Model: TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulin
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRIVIDIA HEALTH, INC.

Primary DI Number: 00021292005795
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 151810868 *Terms of Use

Device Description: TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulin

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):	Yes
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 [?]
K993017	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 0.50 Inch
Total Volume: 1.0 Milliliter
Needle Gauge: 28 Gauge

Device Record Status

Public Device Record Key: d0ec1c03-2a44-4e15-ac42-9344b2319c47
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50096295125349	8	00096295125344		In Commercial Distribution	Case
00096295125344	10	00021292005795		In Commercial Distribution	Box
10087701426084	8	00087701426087		In Commercial Distribution	Case
00087701426087	10	00021292005795		In Commercial Distribution	Box
10021292007291	8	00021292007294	2018-04-16	Not in Commercial Distribution	Case
00021292007294	10	00021292005795	2018-04-16	Not in Commercial Distribution	Box
10021292004962	8	00021292004965		In Commercial Distribution	Case
00021292004965	10	00021292005795		In Commercial Distribution	Box