Duns Number:303562672
Device Description: Unit; 2.5m, Air hose incl. 2x Rectus connector
Catalog Number
00060
Brand Name
Air hose
Version/Model Number
V1.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 19, 2019
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
K014063
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
374e1c05-9597-4a79-8d44-12ee8c86fb3b
Public Version Date
November 20, 2019
Public Version Number
4
DI Record Publish Date
October 27, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 71 |