Duns Number:010712461
Device Description: INFUSION BAGS 1000ML-5 BOXES PER CASE-5 IN EACH BOX-CASE OF 25,ONLY SELL AS CASE
Catalog Number
301-0726PB
Brand Name
Curaplex
Version/Model Number
301-0726PB
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZD
Product Code Name
INFUSOR, PRESSURE, FOR I.V. BAGS
Public Device Record Key
f3539516-c4ae-4521-915c-3484f5373bec
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
June 20, 2017
Package DI Number
00812574029727
Quantity per Package
5
Contains DI Package
00818834020435
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |