Duns Number:800214827
Device Description: Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and des Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals (single unit package).
Catalog Number
0101
Brand Name
Model 7A
Version/Model Number
Single pack
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
P860008,P860008
Product Code
LPA
Product Code Name
System, Esophageal Pacing
Public Device Record Key
0d21a3be-3783-476a-902b-1d51f8662f3f
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
April 03, 2015
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. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 17 |