Duns Number:604208868
Device Description: Nebulizer to Bag Mask Adapter Kit, Standard
Catalog Number
OM2602A
Brand Name
Motion Medical Distributing
Version/Model Number
OM2602A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
7efeb562-8486-4eb4-a1ce-e04995b0537e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 11, 2017
Package DI Number
25060498451684
Quantity per Package
50
Contains DI Package
15060498451687
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |