AccessGUDID - DEVICE: GoodSense Comfort Assist Insulin Syringes (00370030128730)

GUDID

Device Identifier (DI) Information

Brand Name: GoodSense Comfort Assist Insulin Syringes
Version or Model: 053108
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: L PERRIGO COMPANY

Primary DI Number: 00370030128730
Issuing Agency: GS1
Commercial Distribution End Date: July 03, 2018
Device Count: 100
Labeler D-U-N-S® Number*: 006013346 *Terms of Use

Device Description: .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct

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
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062702	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: .5 Milliliter
Needle Gauge: 31 Gauge
Length: 8 Millimeter

Device Record Status

Public Device Record Key: af25e2ff-71df-4a52-9f88-7792d51c3262
Public Version Date: July 11, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016