Duns Number:070556204
Device Description: Custom PHI Vent - Adult Kit
Catalog Number
8600-01126
Brand Name
Curaplex
Version/Model Number
8600-01126
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
BTL
Product Code Name
Ventilator, emergency, powered (resuscitator)
Public Device Record Key
e15703df-8100-4741-a66e-531f47000597
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
December 14, 2016
Package DI Number
00810094572112
Quantity per Package
20
Contains DI Package
00815277022309
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 |