GO IO Intraosseous Start Kit 12/Case - Secure IV and NIO Fixation - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: Secure IV and NIO Fixation

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

GO IO

Brand Name

GO IO Intraosseous Start Kit 12/Case

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

OJA

Product Code Name

Intravenous Extension Tubing Set

Device Record Status

Public Device Record Key

e2c0f575-529a-4554-b89d-d2d7b6fb6480

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48