Duns Number:025460908
Device Description: DBD-NEBULIZER,W/PACIFIER,ELBOW,&7' TUBIN
Catalog Number
HCS5587
Brand Name
Medline
Version/Model Number
HCS5587
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
5d3936d5-909d-4bc3-be2c-ee52c37b5a99
Public Version Date
July 22, 2021
Public Version Number
1
DI Record Publish Date
July 14, 2021
Package DI Number
10888277420632
Quantity per Package
12
Contains DI Package
00888277420635
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 |