Duns Number:025460908
Device Description: DBD-18FR 10ML 100% SIL TEMP SENS
Catalog Number
URO1SPSUM18TD
Brand Name
Medline
Version/Model Number
URO1SPSUM18TD
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
-
Product Code
OHR
Product Code Name
Catheter care tray
Public Device Record Key
bfee81ce-d303-467f-9ec8-2c605140b3cb
Public Version Date
March 25, 2021
Public Version Number
1
DI Record Publish Date
March 17, 2021
Package DI Number
40889942468455
Quantity per Package
10
Contains DI Package
10889942468454
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |