Duns Number:062312574
Device Description: A portable, hand-held, battery-powered suction device designed to enable an adult to gentl A portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a hand grip that contains the batteries, a small electric pump that creates the suction, and a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.
Catalog Number
-
Brand Name
CVS/Pharmacy
Version/Model Number
NS14
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
-
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
JCX
Product Code Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Public Device Record Key
eb935965-2491-4219-8efe-1aeadf5cfcff
Public Version Date
August 08, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
40050428358687
Quantity per Package
12
Contains DI Package
00050428358689
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |