Duns Number:002348191
Device Description: INFANT NASAL CPAP SYSTEM,SZ 4, INTL
Catalog Number
41688
Brand Name
HUDSON RCI
Version/Model Number
IPN044451
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K871157,K871157
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
aef4295d-fae9-4407-995c-1f033b39d463
Public Version Date
March 22, 2022
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
24026704390339
Quantity per Package
10
Contains DI Package
04026704390335
Package Discontinue Date
September 30, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |