Duns Number:734903532
Device Description: IHC607 INSPIRE nCPAP Large Prong
Catalog Number
-
Brand Name
Inspire
Version/Model Number
IHC607
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAT
Product Code Name
CANNULA, NASAL, OXYGEN
Public Device Record Key
0cebc316-c828-49fe-bb2c-b89f67bb941e
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
November 07, 2016
Package DI Number
05060206920132
Quantity per Package
10
Contains DI Package
05060206920125
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 21 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |