Duns Number:483243700
Device Description: iFlow 40 SC Neonatal/Infant Proximal Flow Sensor
Catalog Number
302.578.000
Brand Name
imtmedical
Version/Model Number
302.578.000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 13, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZO
Product Code Name
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Public Device Record Key
ade6a4b3-c3a8-43cd-b585-f9508f30cb4f
Public Version Date
January 21, 2021
Public Version Number
1
DI Record Publish Date
January 13, 2021
Package DI Number
07640149383959
Quantity per Package
10
Contains DI Package
07640149383836
Package Discontinue Date
January 13, 2021
Package Status
Not 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |