Duns Number:070556204
Device Description: Curaplex Total NRB, Infant
Catalog Number
30058
Brand Name
Curaplex
Version/Model Number
30058
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
KGB
Product Code Name
MASK, OXYGEN, NON-REBREATHING
Public Device Record Key
27cea714-02c2-4570-a39d-9f2f1905df05
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
September 04, 2017
Package DI Number
00817617027975
Quantity per Package
50
Contains DI Package
00817617027937
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |