Duns Number:785952607
Device Description: ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, 22F
Catalog Number
-
Brand Name
ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, 22F
Version/Model Number
1516000
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
f23a931c-cb32-42aa-99c6-37713109c8bb
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2021
Package DI Number
05030267026180
Quantity per Package
30
Contains DI Package
05030267053650
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |