Duns Number:008171162
Device Description: Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that h Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.)
Catalog Number
-
Brand Name
Assure® Slide Pill Swallowing Aid zero
Version/Model Number
1000003
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
NXB
Product Code Name
Dispenser, Solid Medication
Public Device Record Key
f71c4505-6ea6-495c-8b26-4af4f2100ab6
Public Version Date
July 23, 2020
Public Version Number
2
DI Record Publish Date
December 28, 2018
Package DI Number
20015482100036
Quantity per Package
24
Contains DI Package
10015482100039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |