Duns Number:015222912
Device Description: miniFlow Nasal Prongs, size x large, single patient use each.
Catalog Number
58405
Brand Name
miniFlow
Version/Model Number
58405
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
K121379,K121379
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
e58dec0d-cb51-460f-a85a-70310e7982d7
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
00853678006283
Quantity per Package
10
Contains DI Package
00853678006276
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |