AccessGUDID - DEVICE: HEB In-Control Insulin Syringe (00041220791446)

GUDID

Device Identifier (DI) Information

Brand Name: HEB In-Control Insulin Syringe
Version or Model: 79144
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 79144
Company Name: H. E. BUTT GROCERY COMPANY

Primary DI Number: 00041220791446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 007924756 *Terms of Use

Device Description: 0.3mL 31G 5/16 (8mm) Single use insulin syringe with needle. Includes 100 sterile syringes.

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
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152879	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
Total Volume: 0.3 Milliliter
Length: 8 Millimeter
Needle Gauge: 31 Gauge

Device Record Status

Public Device Record Key: 1deced68-7203-4d21-95ab-4ef75546ddb2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 04, 2017