Duns Number:025460908
Device Description: NEBULIZER,KIT, ADLT MASK,7' TUBE, SC
Catalog Number
HCS4485VA
Brand Name
Medline
Version/Model Number
HCS4485VA
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
K800562,K800562
Product Code
CAF
Product Code Name
Nebulizer (direct patient interface)
Public Device Record Key
325cb756-ccef-4f8e-a20f-bdf48c18e6a0
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 29, 2021
Package DI Number
20888277420660
Quantity per Package
50
Contains DI Package
10888277420663
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |