Duns Number:025460908
Device Description: BAG,DRAINAGE,4L,A/R TOWER,LL,SLIDE TAP
Catalog Number
DYND25405S
Brand Name
Medline
Version/Model Number
DYND25405S
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
FCN
Product Code Name
Urinary drainage collection kit, for indwelling catheter
Public Device Record Key
43bc9203-40cb-41ec-95a0-7e0cd8c93766
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
November 12, 2020
Package DI Number
40080196004356
Quantity per Package
20
Contains DI Package
10080196004355
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |