Duns Number:134472476
Device Description: IV START KIT-NON-SPLIT DRESSING 1.5ML CHLORAPREP
Catalog Number
-
Brand Name
Regard™
Version/Model Number
405218REG
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
c1339731-87d4-4709-85ef-928422500da8
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
May 03, 2022
Package DI Number
20326053118450
Quantity per Package
100
Contains DI Package
10326053118453
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 558 |