Duns Number:022721133
Device Description: Adult Nasal High Performance Sensor Cannula 7 1/4" Connect Tubing P/N: 29-4401 Disposable Adult Nasal High Performance Sensor Cannula 7 1/4" Connect Tubing P/N: 29-4401 Disposable Single Patient Use Only.Note: incorrect DI, see ABM SO number for 5530-0, reference.
Catalog Number
SO-1990
Brand Name
n/a
Version/Model Number
SO-1990
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 24, 2020
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"
Yes
For Single-Use
-
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
K151874,K151874
Product Code
MNR
Product Code Name
VENTILATORY EFFORT RECORDER
Public Device Record Key
908a4ad4-6c71-4f9a-936d-f23bf5417357
Public Version Date
July 27, 2020
Public Version Number
5
DI Record Publish Date
November 30, 2016
Package DI Number
10607411801126
Quantity per Package
10
Contains DI Package
00607511801128
Package Discontinue Date
July 24, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |