Duns Number:053146767
Device Description: The CB 23-1 Flowmeter / Air Compressor Adapter connects a flowmeter or air compressor dir The CB 23-1 Flowmeter / Air Compressor Adapter connects a flowmeter or air compressor directly to large-bore 22 mm I.D. tubing. Can be used with high gas flows for CPAP. Has a security chain to help prevent loss.
Catalog Number
CB 23-1
Brand Name
CB 23-1 Flowmeter / Air Compressor Adapter
Version/Model Number
CB 23-1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
98565f54-f214-4284-b029-901a1de61dcf
Public Version Date
November 04, 2019
Public Version Number
3
DI Record Publish Date
July 30, 2018
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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |