Duns Number:154454730
Catalog Number
MC-1423
Brand Name
Metered Dose Elbow
Version/Model Number
MC-1423
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
c387c3eb-7305-4eb4-b8e7-c14d0ac76622
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 11, 2017
Package DI Number
10858409005396
Quantity per Package
50
Contains DI Package
00858409005399
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 | 53 |
2 | A medical device with a moderate to high risk that requires special controls. | 5 |