Duns Number:790605856
Device Description: Ice Bath Temperature Probe Reusable static temperature probe to measure cardiac output usi Ice Bath Temperature Probe Reusable static temperature probe to measure cardiac output using an ice bath and syringes; Length(including probe) = 10' (3m); Wgt = 3 oz (85g)
Catalog Number
23002A
Brand Name
Temperature Probes
Version/Model Number
Ice Bath 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"
-
For Single-Use
-
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
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
ea0e8dfb-a5eb-4496-9790-625bedb682d7
Public Version Date
March 03, 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 |