Duns Number:025460908
Device Description: 1LYRTR VENT ADDACATH DB SNAP
Catalog Number
URO185100
Brand Name
Medline Industries, Inc.
Version/Model Number
URO185100
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
73e18b2d-c44f-4ff5-8d44-1c8e1a356bcc
Public Version Date
July 19, 2022
Public Version Number
1
DI Record Publish Date
July 11, 2022
Package DI Number
40193489987714
Quantity per Package
10
Contains DI Package
10193489987713
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 |