Duns Number:537208717
Device Description: The laryngoscopes are manufactured in order to be used for endotracheal intubation.The Rie The laryngoscopes are manufactured in order to be used for endotracheal intubation.The Riester battery handles are used in order to supply the bulbs with energy and for fixation of the blades.
Catalog Number
8158
Brand Name
ri-modul set Miller baby LED 3.5 V with AA-handle
Version/Model Number
8158
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945425
Product Code
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
c8fdbdd1-3799-4d30-b483-80a1206a28cc
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |