Duns Number:099674145
Device Description: Resuscitator, LSP, EMT, Swedish, WI Hose Assy. and AGA FTG.
Catalog Number
L576-SWE
Brand Name
Life Support Proucts (LSP)
Version/Model Number
L576-SWE
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K915564
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
661f5112-711e-428d-a961-1c41ed778f93
Public Version Date
January 13, 2020
Public Version Number
4
DI Record Publish Date
November 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1099 |