Duns Number:800214827
Device Description: 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit package).
Catalog Number
200
Brand Name
Tapscope
Version/Model Number
550, 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
6825fb48-8986-4da4-886b-b022399fe2c0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 2015
Package DI Number
20856233005008
Quantity per Package
25
Contains DI Package
00856233005004
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 |