AccessGUDID - DEVICE: Biotronix Healthcare Syringes (00858835007400)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronix Healthcare Syringes
Version or Model: GE12004-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Primary DI Number: 00858835007400
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 065762392 *Terms of Use

Device Description: Disposable 1CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16"

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):	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 [?]
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
Device Size Text, specify: CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16

Device Record Status

Public Device Record Key: 0a9a2c53-e8ab-4d25-b4ae-900ba0472e0d
Public Version Date: December 24, 2019
Public Version Number: 2
DI Record Publish Date: September 29, 2019