Duns Number:827221698
Device Description: ZZZ Mask Full Face, Large w/ Headgear
Catalog Number
-
Brand Name
Roscoe Medical
Version/Model Number
PB7800L
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
0fdb60be-cf1f-4e85-99ba-17616c7af4e9
Public Version Date
January 11, 2019
Public Version Number
1
DI Record Publish Date
December 11, 2018
Package DI Number
30092237619699
Quantity per Package
50
Contains DI Package
00092237619698
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 | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |