Duns Number:038305402
Device Description: Antistatic Spacer w/ Size 3 Intersurgical Mask
Catalog Number
-
Brand Name
Ventlab
Version/Model Number
PRO-6213
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
abdfee27-92aa-473a-a02f-3f36f50789bd
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
20889483105730
Quantity per Package
20
Contains DI Package
10889483105733
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 612 |