Duns Number:080935429
Device Description: Enema Bag and Tube,Pre-Lubricated Tip
Catalog Number
145541
Brand Name
Dover
Version/Model Number
145541
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCE
Product Code Name
Enema kit
Public Device Record Key
ce1dfad4-a1b1-4b47-96e3-4b34ae6944d4
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 22, 2018
Package DI Number
20884521007908
Quantity per Package
50
Contains DI Package
10884521007901
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |