Duns Number:014578892
Device Description: RITE AID TRAVEL DOUCHE
Catalog Number
-
Brand Name
RITE AID PHARMACY
Version/Model Number
02700RA1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HED
Product Code Name
Douche Apparatus, Vaginal, Therapeutic
Public Device Record Key
bda7ffe0-93b8-4d81-92f7-6b35ceeaa69e
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
10025715002603
Quantity per Package
12
Contains DI Package
00011822314862
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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
U | Unclassified | 2 |