Duns Number:658122049
Device Description: HP-2558 Nebulizer Kit(Child) includes: nebulizer bottle x 1pc, nebulizer mask(child) x 1pc HP-2558 Nebulizer Kit(Child) includes: nebulizer bottle x 1pc, nebulizer mask(child) x 1pc, oxygen tube(HP-1108-7E-B, universal nut & standard connector) x 1 pc
Catalog Number
-
Brand Name
HEADSTAR
Version/Model Number
HP-2558
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
17a3d833-1966-4a93-a302-90e8304c98b6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 11, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |