Duns Number:096372255
Device Description: INTL-DRESSING KIT FOR CENTRAL LINE PGYBK
Catalog Number
89-10112
Brand Name
DeRoyal
Version/Model Number
89-10112
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
PEZ
Product Code Name
Central venous catheter dressing change kit
Public Device Record Key
378edaa0-3cee-4e4f-82b2-0d8896277857
Public Version Date
October 06, 2020
Public Version Number
3
DI Record Publish Date
March 14, 2019
Package DI Number
50749756975785
Quantity per Package
60
Contains DI Package
00749756975780
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 | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |