Catalog Number

-

Brand Name

10MM FLEXTUBE B/S WITH NEONATAL WATER TRAPS, MONITORING LINE AND 0.5M LIMB, 1.6M

Version/Model Number

4510000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

0e32805b-6f4c-4356-bcb4-9e058d46a2e6

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

October 15, 2021

Package DI Number

05030267046768

Quantity per Package

15

Contains DI Package

05030267067589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-