Duns Number:590153276
Device Description: KIT RESUS ADJ MSK50 10
Catalog Number
0W90
Brand Name
FISHER & PAYKEL HEALTHCARE
Version/Model Number
RD1350-10
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
K892885,K892885
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
5c66fdd1-7d0f-45a3-8044-4cfc2d89e8a8
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 25, 2015
Package DI Number
09420012424235
Quantity per Package
10
Contains DI Package
09420012430045
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 159 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |