Duns Number:025460908
Device Description: MASK, NIV, FULL FACE, VENT, AAV, SMALL
Catalog Number
HCSFFVAS
Brand Name
Medline
Version/Model Number
HCSFFVAS
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
K102120,K102120
Product Code
CBK
Product Code Name
Ventilator, continuous, facility use
Public Device Record Key
938a5bc0-4fca-425a-b5f0-862862bad733
Public Version Date
January 15, 2021
Public Version Number
1
DI Record Publish Date
January 07, 2021
Package DI Number
20193489021476
Quantity per Package
10
Contains DI Package
10193489021479
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 |