Catalog Number

CR2054

Brand Name

5570 3L SYRINGE

Version/Model Number

5570

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BXW

Product Code Name

Calibrator, Volume, Gas

Public Device Record Key

35cf9f29-5389-4835-b333-ead3cbb7447a

Public Version Date

May 19, 2021

Public Version Number

1

DI Record Publish Date

May 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-