Duns Number:025460908
Device Description: NEBULIZER,KIT,TMTHPIECE,6"RESR,14'TUB,UC
Catalog Number
HCSU448314
Brand Name
MEDLINE INDUSTRIES
Version/Model Number
HCSU448314
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
K091272,K091272
Product Code
CAF
Product Code Name
Nebulizer (direct patient interface)
Public Device Record Key
0337e671-71d8-46ec-a473-e5545ea61bda
Public Version Date
October 11, 2021
Public Version Number
1
DI Record Publish Date
October 01, 2021
Package DI Number
20888277699233
Quantity per Package
50
Contains DI Package
10888277699236
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 |