Duns Number:200103823
Device Description: Rescuer II Compact CPAP System with Large Deluxe CPAP Mask and nebulizer kit
Catalog Number
8800-NK
Brand Name
Rescuer II Compact CPAP with Nebulizer Kit
Version/Model Number
8800-NK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K122610,K122610
Product Code
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
d53f1230-ecc4-4e48-91c8-a53daf47369b
Public Version Date
November 02, 2018
Public Version Number
1
DI Record Publish Date
October 02, 2018
Package DI Number
B0028800NK1
Quantity per Package
6
Contains DI Package
B0028800NK0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |