Duns Number:002348191
Device Description: INFANT NASAL CPAP SYSTEM,SIZE 0
Catalog Number
1683
Brand Name
HUDSON RCI
Version/Model Number
IPN913699
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
K871157,K871157,K871157
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
b723cdc6-6f1d-46cd-a58c-18099b44a9cc
Public Version Date
October 26, 2022
Public Version Number
5
DI Record Publish Date
July 17, 2019
Package DI Number
24026704659047
Quantity per Package
10
Contains DI Package
14026704659040
Package Discontinue Date
October 25, 2022
Package Status
Not 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |