Duns Number:341625331
Device Description: Pneumotachograph tube, accessory, single-patient use
Catalog Number
-
Brand Name
ERT PT
Version/Model Number
ERT PT
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
K173937,K202754,K173937,K202754,K173937,K202754
Product Code
BTY
Product Code Name
Calculator, Predicted Values, Pulmonary Function
Public Device Record Key
f9399e8d-13c6-49b1-94ad-8a6244c9def4
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
February 25, 2019
Package DI Number
04057155000436
Quantity per Package
50
Contains DI Package
04057155000412
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |