Duns Number:688006266
Device Description: The linking screw is an accessory for insulin pump use. The role is to change the rotary m 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.
Catalog Number
-
Brand Name
2 Linking Screws
Version/Model Number
Linking screw
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 25, 2018
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063126
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |