Duns Number:825673239
Device Description: AMSure® Cleansing Enema Bucket SetCONTENTS:1 each 1500 mL Graduated Container1 each 60" Ad AMSure® Cleansing Enema Bucket SetCONTENTS:1 each 1500 mL Graduated Container1 each 60" Administration Tubing with Prelubricated Tip1 each Flow Control Clamp1 each Packet Castile Soap1 each Moistureproof Underpad
Catalog Number
AS333
Brand Name
AMSure® Cleansing Enema Bucket 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
26e2f664-c89f-4a27-affb-5e22c6dec050
Public Version Date
July 06, 2018
Public Version Number
1
DI Record Publish Date
June 05, 2018
Package DI Number
40704411008386
Quantity per Package
50
Contains DI Package
10704411008385
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 |