Catalog Number

187126

Brand Name

PFT Kit I

Version/Model Number

PFT Kit I, VBMax 36S, w/ White Foam Noseclips - 187126

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

-

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

-

FDA Premarket Submission

K000654,K000654

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

fcf28fe4-355e-4f69-a5d4-4ef6e420eeec

Public Version Date

May 19, 2020

Public Version Number

1

DI Record Publish Date

May 11, 2020

Package DI Number

00817081026689

Quantity per Package

100

Contains DI Package

00817081026672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-