Duns Number:248200149
Device Description: BOMImed Disposable Saver Laryngoscope Blade
Catalog Number
OL-3312
Brand Name
BOMImed Saver
Version/Model Number
MAC 2
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"
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
-
Product Code
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
5aa01c48-b3a7-4c25-a12c-f75a72939042
Public Version Date
August 16, 2021
Public Version Number
1
DI Record Publish Date
August 06, 2021
Package DI Number
20629160000039
Quantity per Package
20
Contains DI Package
10629160000032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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. | 1 |