Duns Number:590153276
Device Description: Slepstyle Standard Breathing Tube with Elbow
Catalog Number
900SPS121
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
900SPS121
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173193,K173193
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
28cd2f5b-56fd-4c55-a225-f88364ff52e2
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
May 12, 2019
Package DI Number
09420012448354
Quantity per Package
40
Contains DI Package
09420012442260
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 |