Catalog Number
-
Brand Name
E.M Adams co, inc.
Version/Model Number
EP26-63340XL-1
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)
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
960e444b-cbe2-49ee-b7f5-7adc9f7b4e04
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 2021
Package DI Number
50840200307333
Quantity per Package
48
Contains DI Package
10840200307342
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 | 1447 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |