Duns Number:002065670
Device Description: Manometer, Crystal Replacement, Fits Pre 2013 year 00-199, 00-274, 00-275 type Gauges
Catalog Number
P-158
Brand Name
AincA®
Version/Model Number
P-158
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
CAP
Product Code Name
MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
Public Device Record Key
76e051e9-38f4-43ae-bb61-29177a27dd7e
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 561 |
2 | A medical device with a moderate to high risk that requires special controls. | 135 |