Duns Number:788472314
Device Description: The ADAP II is designed to interface between the Seamed Pacing System Analyzer and Remingt The ADAP II is designed to interface between the Seamed Pacing System Analyzer and Remington's cable models S-101-97 and S-201-97.
Catalog Number
ADAP II
Brand Name
Safety Adapter
Version/Model Number
ADAP II
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
0408a6d6-9619-441f-a548-b449a0e883e7
Public Version Date
November 06, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
10813079020148
Quantity per Package
25
Contains DI Package
00813079020141
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 |