Catalog Number

-

Brand Name

BAIXIN

Version/Model Number

1MLLS2515

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

K083686,K083686,K083686

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

58223310-cc71-4b86-99e1-1f0b0f15f9ac

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Package DI Number

06936018500147

Quantity per Package

2400

Contains DI Package

06936018500130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case