AccessGUDID - DEVICE: 2 Linking Screws (08809220581007)

GUDID

Device Identifier (DI) Information

Brand Name: 2 Linking Screws
Version or Model: Linking screw
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SOOIL DEVELOPMENT CO.,LTD

Primary DI Number: 08809220581007
Issuing Agency: GS1
Commercial Distribution End Date: May 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 688006266 *Terms of Use

Device Description: The linking screw is an accessory for insulin pump use. The role is to change the rotary motion of the motor in insulin pump to rectilinear motion of plunger in insulin syringe reservoir.

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:	No
Prescription Use (Rx):	No
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?
35983	Ambulatory insulin infusion pump, electronic	A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063126	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 11226483-3d5d-4239-a26f-d2d44d9fbd2f
Public Version Date: September 12, 2018
Public Version Number: 3
DI Record Publish Date: May 24, 2018