Duns Number:825673239
Device Description: AMSure® Cleansing Enema SetCONTENTS:1, One (1) each 1500 mL Enema Bag: -Pre-lubricated Tip AMSure® Cleansing Enema SetCONTENTS:1, One (1) each 1500 mL Enema Bag: -Pre-lubricated Tip - Tubing Clamp2, Moisture Proof Drape3, Enema Soap Packet
Catalog Number
AS330
Brand Name
AMSure® Cleansing Enema Set
Version/Model Number
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
FCE
Product Code Name
Enema Kit
Public Device Record Key
d690f5d9-29e0-43c8-bab6-929694422247
Public Version Date
July 06, 2018
Public Version Number
1
DI Record Publish Date
June 05, 2018
Package DI Number
40704411008379
Quantity per Package
50
Contains DI Package
10704411008378
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |