Duns Number:790605856
Device Description: Esophageal/Stethoscope Temperature Probe Disposable; size = 18Fr; probe length = 18" (46cm Esophageal/Stethoscope Temperature Probe Disposable; size = 18Fr; probe length = 18" (46cm); sterile, minimum shelf life = 12 months; 1cs = 20 probes; wgt = 1lb (454g)
Catalog Number
21094A
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
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)
-
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
f5138edc-0df4-4ae4-af2d-6c2fee33d670
Public Version Date
March 04, 2022
Public Version Number
6
DI Record Publish Date
December 05, 2016
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 |