Duns Number:825179992
Device Description: CPAP Tubing, 8 ft, single-pack
Catalog Number
-
Brand Name
CPAP Tubing
Version/Model Number
CTUB-080-1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
49c078de-eefa-4e0d-96ad-900a641a820b
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
10819989011061
Quantity per Package
50
Contains DI Package
00819989011064
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |