Duns Number:790605856
Device Description: Esophageal/Stethoscope Temperature Probe Disposable; size = 24 Fr; probe length = 18" (46c Esophageal/Stethoscope Temperature Probe Disposable; size = 24 Fr; probe length = 18" (46cm); sterile; minimum shelf life = 12 months; 1cs = 20 probes; wgt = 1lb (454g)
Catalog Number
21095A
Brand Name
Temperature Probes
Version/Model Number
Esophageal/Stethoscope Temperature Probe
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZT
Product Code Name
STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
Public Device Record Key
90fdfb0c-5688-4f82-98ce-d3949eb2b5eb
Public Version Date
March 04, 2022
Public Version Number
6
DI Record Publish Date
June 09, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |