AccessGUDID - DEVICE: Sure Comfort (00786227650357)

GUDID

Device Identifier (DI) Information

Brand Name: Sure Comfort
Version or Model: 22-6503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22-6503
Company Name: ALLISON MEDICAL, INC.

Primary DI Number: 00786227650357
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 825097264 *Terms of Use

Device Description: 0.3mL 31G 8mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags.

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

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
Needle Gauge: 31 Gauge
Length: 8 Millimeter
Total Volume: 0.3 Milliliter

Device Record Status

Public Device Record Key: 1fbc146b-12ac-40e4-8a74-392246ffdbaa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 03, 2016