Catalog Number
-
Brand Name
E.M Adams co, inc.
Version/Model Number
EP26-63350-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2021
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)
Yes
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
8c67db1b-df6a-4df4-a5d5-934b49f15470
Public Version Date
March 01, 2021
Public Version Number
3
DI Record Publish Date
December 31, 2019
Package DI Number
58100013407357
Quantity per Package
48
Contains DI Package
18100013407366
Package Discontinue Date
February 28, 2021
Package Status
Not 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 | 1447 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |