Duns Number:825673239
Device Description: AMSure® Oxygen MaskPediatric ElongatedHigh Concentration with 7 ft Star Tubing
Catalog Number
AS74080
Brand Name
AMSure® Oxygen Mask
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
2db60d7c-8f9c-4247-a894-cc4b2eb91e4f
Public Version Date
September 07, 2018
Public Version Number
1
DI Record Publish Date
August 07, 2018
Package DI Number
40704411009604
Quantity per Package
50
Contains DI Package
10704411009603
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 |