Duns Number:025460908
Device Description: NEB,KIT,REUSABLE,TEE MP,6"RES,7'TB,SC
Catalog Number
HCS4483R
Brand Name
Medline
Version/Model Number
HCS4483R
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
-
Product Code
CAF
Product Code Name
Nebulizer (direct patient interface)
Public Device Record Key
3410fb75-3927-49da-bc74-5d13a8aef755
Public Version Date
December 09, 2020
Public Version Number
1
DI Record Publish Date
December 01, 2020
Package DI Number
40080196418337
Quantity per Package
50
Contains DI Package
10080196418336
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 |