AccessGUDID - DEVICE: Comfort Assist Insulin Syringe (00070030510695)

GUDID

Device Identifier (DI) Information

Brand Name: Comfort Assist Insulin Syringe
Version or Model: 032912
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: L PERRIGO COMPANY

Primary DI Number: 00070030510695
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2017
Device Count: 10
Labeler D-U-N-S® Number*: 006013346 *Terms of Use

Device Description: .3cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 10ct

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
FMI	Needle, Hypodermic, Single Lumen
FMF	Syringe, Piston

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
Length: 12.7 Millimeter
Needle Gauge: 29 Gauge
Total Volume: .3 Milliliter

Device Record Status

Public Device Record Key: a8022522-ff4d-4d6a-8121-6c1e7f67b7b7
Public Version Date: July 10, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016