Duns Number:097462979
Device Description: Direct Suction Adaptor
Catalog Number
CCFDSA01
Brand Name
Med Alliance
Version/Model Number
CCFDSA01
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
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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
3290b154-f4f4-4a3b-aa34-438f5064dd8b
Public Version Date
September 21, 2022
Public Version Number
3
DI Record Publish Date
March 27, 2018
Package DI Number
10817278012645
Quantity per Package
25
Contains DI Package
00817278012648
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 91 |