Duns Number:079628327
Device Description: Convenience Kit: Portless Vinyl Mask (Adult) with Adapter (HL-22), Bacterial/Viral Filter Convenience Kit: Portless Vinyl Mask (Adult) with Adapter (HL-22), Bacterial/Viral Filter, Ultra-Flex tubing (extends 6-24 inches), Aerosol Flow Tee, and End Cap.
Catalog Number
-
Brand Name
Healthline, Medicator
Version/Model Number
AM-608AK
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"
Yes
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
K960397,K960397
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
69f2152d-2630-4826-bb82-1a795ef3aa6d
Public Version Date
April 26, 2022
Public Version Number
1
DI Record Publish Date
April 18, 2022
Package DI Number
00850022357732
Quantity per Package
10
Contains DI Package
00850022357725
Package Discontinue Date
-
Package Status
In Commercial Distribution
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. | 90 |