Catalog Number

AC2100210

Brand Name

12 Pneumo-opt Slp Probes for Watch-PAT 200S-3

Version/Model Number

12 Pneumo-opt Slp Probes for Watch-PAT 200S-3

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

K081037,K081982,K102567,K081037,K081982,K102567

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

672d12a4-f21c-48ea-920b-f1560169d15a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 06, 2016

Package DI Number

07290109222028

Quantity per Package

1

Contains DI Package

07290109222004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-