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
MCR
Version/Model Number
MCRTM-A
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)
Yes
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
eb3c68ca-d184-4635-8705-9ca532f8d0a7
Public Version Date
January 31, 2019
Public Version Number
1
DI Record Publish Date
December 31, 2018
Package DI Number
26946430400950
Quantity per Package
80
Contains DI Package
16946430400953
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 |