Duns Number:022721133
Device Description: Nasal-Aire II Petite Cannula - Size B, pack of 14
Catalog Number
PB412
Brand Name
N/A
Version/Model Number
PB412
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
b33f060c-8aae-40bb-bdd5-951c6484c2b6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 2017
Package DI Number
10607411945424
Quantity per Package
112
Contains DI Package
00607411945427
Package Discontinue Date
-
Package Status
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 |