Duns Number:867673159
Device Description: RespiratoryRespiratory Disposables Product Description: No-Kink Oxygen Tubing,25 ft, 25/cs
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
TUB NK 50
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
4e93c496-c14d-4911-995b-39af0318ca3d
Public Version Date
July 17, 2019
Public Version Number
4
DI Record Publish Date
May 19, 2017
Package DI Number
00822383116648
Quantity per Package
20
Contains DI Package
50822383116643
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |