Duns Number:800214827
Device Description: 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a femal 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a female temperature connector, (single unit package).
Catalog Number
250
Brand Name
Tapscope
Version/Model Number
550F, 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
Yes
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,P860008,P860008,P860008,P860008
Product Code
BZT
Product Code Name
Stethoscope, Esophageal, With Electrical Conductors
Public Device Record Key
3d29f27a-247b-4dd0-bd50-6653538dcd31
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 08, 2015
Package DI Number
20856233005015
Quantity per Package
25
Contains DI Package
00856233005011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 25 units
| 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 |