Duns Number:042763706
Device Description: PREPUNCHED AUTOCLAVABLE NASAL HOODS BLUE, LARGE 3/PKG NEW 3/2014
Catalog Number
0039680
Brand Name
ACE
Version/Model Number
0039680
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
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
428abe6f-c607-440e-9779-b061fcf781d0
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
October 21, 2015
Package DI Number
10614950000262
Quantity per Package
3
Contains DI Package
00614950000265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Poly Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |