Duns Number:070556204
Device Description: Curaplex Bag Valve Mask (BVM), Pediatric, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
Catalog Number
30071
Brand Name
Curaplex
Version/Model Number
30071
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
K053466,K053466
Product Code
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
185b16c5-4366-48e3-b019-3b93f59f5292
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 22, 2017
Package DI Number
00817617024356
Quantity per Package
12
Contains DI Package
00817617024226
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 |