Duns Number:002065670
Device Description: Respirometer Guard - Fits Mark 12, 20, and Haloscale Standard, w/Closure O-Rings, Black Ne Respirometer Guard - Fits Mark 12, 20, and Haloscale Standard, w/Closure O-Rings, Black Neoprene
Catalog Number
00-147
Brand Name
AincA®
Version/Model Number
00-147
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
BZK
Product Code Name
Spirometer, monitoring (w/wo alarm)
Public Device Record Key
8cd86c14-5fb7-42d2-9566-39c637b70d38
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 |