GO IO - Intraosseous Start Kit - EINSTEIN WORKS, LLC

Duns Number:098121274

Device Description: Intraosseous Start Kit

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More Product Details

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

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

eda203be-f529-4d87-b4a3-f14221687411

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

September 01, 2020

Additional Identifiers

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

"EINSTEIN WORKS, LLC" Characteristics
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