Duns Number:022721133
Device Description: Nasal Cannula (adult) Salter Style with 9’ (2.7 m) supply tube 00060741110024-- incorrect Nasal Cannula (adult) Salter Style with 9’ (2.7 m) supply tube 00060741110024-- incorrect GUDID. Correct # on part number 1600-9, package level for 50, GUDID 10607411100274
Catalog Number
1600-9-50
Brand Name
N/A
Version/Model Number
1600-9-50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 08, 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
-
Product Code
CAT
Product Code Name
CANNULA, NASAL, OXYGEN
Public Device Record Key
95228a7d-d531-4677-9ff3-4616c6081542
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
November 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |