Duns Number:025460908
Device Description: MASK,OXY,ADLT,NON-REB,SAFETY VENT,7,UC
Catalog Number
HCSU4640B
Brand Name
Medline
Version/Model Number
HCSU4640B
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
BYF
Product Code Name
MASK, OXYGEN, LOW CONCENTRATION, VENTURI
Public Device Record Key
90357d8c-19d9-4fb2-8a3d-2d618f5b5bdc
Public Version Date
July 21, 2021
Public Version Number
1
DI Record Publish Date
July 13, 2021
Package DI Number
40884389966427
Quantity per Package
50
Contains DI Package
10884389966426
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 |