Duns Number:825673239
Device Description: AMSafe® Nasal Oxygen CannulaPediatric, Non-Flared tip with 213cm (84″)Tubing (Over the Ear AMSafe® Nasal Oxygen CannulaPediatric, Non-Flared tip with 213cm (84″)Tubing (Over the Ear Style)
Catalog Number
AS75090
Brand Name
AMSafe® Nasal Oxygen Cannula
Version/Model Number
1
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
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
-
Product Code
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
bb4f736f-99b9-4abb-b2d1-89079ed3ebd5
Public Version Date
June 21, 2018
Public Version Number
1
DI Record Publish Date
May 21, 2018
Package DI Number
40704411008010
Quantity per Package
50
Contains DI Package
10704411008019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |