Duns Number:788472314
Device Description: The ADAP 2R is designed to interface between the Biotronik Pacing System Analyzer (Model E The ADAP 2R is designed to interface between the Biotronik Pacing System Analyzer (Model ERA 300) and Remington's cable models S-101-97 and S-201-97.
Catalog Number
ADAP-2R
Brand Name
Safety Adapter
Version/Model Number
ADAP-2R
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
b3463db8-befb-4347-932c-593df91a2292
Public Version Date
November 06, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
10813079020155
Quantity per Package
25
Contains DI Package
00813079020158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |