Duns Number:658122049
Device Description: VENTURI MASK KIT - CHILDCHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT) VENTURI MASK KIT - CHILDCHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT)Package: 50 PCS in CS
Catalog Number
-
Brand Name
HEADSTAR
Version/Model Number
HP-8609
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
BYF
Product Code Name
Mask, Oxygen, Low Concentration, Venturi
Public Device Record Key
54e8f74b-85c7-4ba5-8234-1545da8e9405
Public Version Date
April 03, 2020
Public Version Number
1
DI Record Publish Date
March 26, 2020
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 |