Duns Number:961027315
Device Description: PICC Line Drape
Catalog Number
C2351
Brand Name
CONVERTORS
Version/Model Number
C2351
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2022
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
ce93b643-93a6-41a2-873c-237a77bfcba8
Public Version Date
June 07, 2022
Public Version Number
8
DI Record Publish Date
July 14, 2016
Package DI Number
50885380071391
Quantity per Package
20
Contains DI Package
10885380071393
Package Discontinue Date
June 07, 2022
Package Status
Not 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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |