Duns Number:025460908
Device Description: TRAY TTL VENT LTX DB 16FR
Catalog Number
URO180116
Brand Name
Medline
Version/Model Number
URO180116
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
f66829db-4e86-4b3d-9a6a-034ad73aef7b
Public Version Date
November 17, 2021
Public Version Number
1
DI Record Publish Date
November 09, 2021
Package DI Number
20888277716091
Quantity per Package
10
Contains DI Package
10888277716094
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 |