Duns Number:543482946
Device Description: Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthes Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile product for single patient use.
Catalog Number
-
Brand Name
Compower
Version/Model Number
4-N#
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
4c72f3f0-f4dd-430a-b040-30d9d9ff1c39
Public Version Date
July 26, 2019
Public Version Number
1
DI Record Publish Date
July 18, 2019
Package DI Number
16946430401837
Quantity per Package
150
Contains DI Package
06946430401830
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |