Duns Number:141668116
Device Description: Adult Cannula with 7ft Supply Tube - with Ear Cushions
Catalog Number
RES1107EC
Brand Name
Adult Cannula with 7ft Supply Tube - with Ear Cushions
Version/Model Number
RES1107EC
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
-
Prescription Use (Rx)
-
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
5b1c768d-6889-485a-b798-055c2305271f
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 19, 2018
Package DI Number
10848530061200
Quantity per Package
25
Contains DI Package
00848530061203
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |