Duns Number:141668116
Device Description: Bag for Compressor Nebulizer
Catalog Number
NEB100-BAG
Brand Name
Bag for Compressor Nebulizer
Version/Model Number
NEB100-BAG
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
bbbb95e2-5f2c-4e55-bf78-c879ed7d4aa5
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
May 29, 2018
Package DI Number
10848530087965
Quantity per Package
50
Contains DI Package
00848530087968
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |