Duns Number:341625331
Device Description: Set of three rotary flow sensors for single-patient use, accessory to Asthma Monitor
Catalog Number
-
Brand Name
Rotationsflowgeber Set
Version/Model Number
Rotationsflowgeber Set
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
K090486,K092890,K133722
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
4d9a587c-c03e-48df-bf72-217ab15c9b59
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
July 15, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |