Duns Number:002348191
Device Description: DISPOSABLE TEMPERATURE PROBE - 72 inches
Catalog Number
872-DTP
Brand Name
HUDSON RCI
Version/Model Number
IPN049339
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"
Yes
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
K131912,K131912
Product Code
BTT
Product Code Name
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Public Device Record Key
18760f93-a66f-498a-91a3-e3488c996ff3
Public Version Date
October 03, 2018
Public Version Number
2
DI Record Publish Date
July 30, 2018
Package DI Number
24026704629064
Quantity per Package
10
Contains DI Package
14026704629067
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |