Duns Number:098121274
Device Description: Intraosseous Start Kit
Catalog Number
-
Brand Name
GO IO
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJA
Product Code Name
Intravenous Extension Tubing Set
Public Device Record Key
eda203be-f529-4d87-b4a3-f14221687411
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
00860017001212
Quantity per Package
12
Contains DI Package
00860017001205
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case as each
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |