Duns Number:658122049
Device Description: HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask (adult) x 1 HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask (adult) x 1pc, oxygen tube x 1pc.
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
K121770
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
000daa91-96c5-4b2c-8140-5d69b4ee7086
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 06, 2018
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 |