Duns Number:010712461
Device Description: Curaplex Select Resuscitation Bag, Adult, #5 Mask, 7 ft Oxygen Tubing, Reservoir, Handle, Curaplex Select Resuscitation Bag, Adult, #5 Mask, 7 ft Oxygen Tubing, Reservoir, Handle, Standard Connector
Catalog Number
301-C1500S
Brand Name
Curaplex
Version/Model Number
301-C1500S
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"
-
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
K021442,K021442
Product Code
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
a5ffbaec-00dd-4b01-b808-2da1995a2577
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 05, 2017
Package DI Number
00818834028011
Quantity per Package
10
Contains DI Package
00818834027984
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 | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |