Catalog Number
-
Brand Name
ALERTCARE
Version/Model Number
HL100A
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081738,K081738,K081738
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
e4f28cd0-16f9-40e3-b902-56fc2946986d
Public Version Date
June 19, 2020
Public Version Number
1
DI Record Publish Date
June 11, 2020
Package DI Number
14719872486043
Quantity per Package
12
Contains DI Package
04719872486046
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 37 |