AccessGUDID - DEVICE: DANA 3cc Syringe (08809220580765)

GUDID

Device Identifier (DI) Information

Brand Name: DANA 3cc Syringe
Version or Model: DANA 3cc Syringe
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SOOIL DEVELOPMENT CO.,LTD

Primary DI Number: 08809220580765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688006266 *Terms of Use

Device Description: DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients.

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):	No
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?
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRZ	Accessories, Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071418	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
Weight: 7.4 Gram
Outer Diameter: 14.4 Millimeter
Needle Gauge: 26 Gauge

Device Record Status

Public Device Record Key: b84b5142-c168-4cf7-99c3-17e2402f5bdb
Public Version Date: August 23, 2018
Public Version Number: 4
DI Record Publish Date: August 12, 2016