Duns Number:032705659
Catalog Number
-
Brand Name
NuFLO2 Hyperinflation System
Version/Model Number
10-56806
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K001714,K001714
Product Code
NHK
Product Code Name
Resuscitator,Manual,Non Self-Inflating
Public Device Record Key
d8ca70a7-dc03-4a2f-ba64-6c93965b798d
Public Version Date
May 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
30641043568068
Quantity per Package
20
Contains DI Package
10641043568064
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 120 |
2 | A medical device with a moderate to high risk that requires special controls. | 728 |