Duns Number:053146767
Device Description: The RB 004 Gauge Rail Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The The RB 004 Gauge Rail Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The RB 004 is used to securely mount Gauges with a rear 1/4" NPT thread to rails. For use with Fairfield-style rails only.
Catalog Number
RB 004
Brand Name
RB 004 Gauge Rail Clamp
Version/Model Number
RB 004
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081778
Product Code
CAP
Product Code Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Public Device Record Key
5d70bfe3-ccc5-4a2c-b554-dd8700ccfdbd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 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 |