Duns Number:053146767
Device Description: BE 169 Oxygen Tank Wrench with 12" Security Cable. Wrench fits the valve stem of E-cylind BE 169 Oxygen Tank Wrench with 12" Security Cable. Wrench fits the valve stem of E-cylinder-type oxygen tanks and is manufactured of zinc-plated steel. The security cable is Nylon-coated stainless steel.
Catalog Number
-
Brand Name
BE 169 Oxygen Tank Wrench with Security Cable
Version/Model Number
BE 169
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"
-
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
2815c258-0364-4648-bf50-214e34c20d85
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 31, 2017
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 |