Duns Number:053146767
Device Description: The CI-55 Anesthesia Holster is a device used to store and handle soiled laryngoscope blad The CI-55 Anesthesia Holster is a device used to store and handle soiled laryngoscope blades and suction tips to prevent cross contamination and pathogen transmission in the anesthesia work area during intubation of a patient . The CI-55 Anesthesia Holster allows for safe storage and handling of contaminated items such as laryngoscope blades and suction tips until they can be discarded or sent for re-processing. This device is Single Patient Use. Packaged as non-sterile.
Catalog Number
CI-55
Brand Name
CI-55 Anesthesia Holster
Version/Model Number
CI-55
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
349cab46-a103-4568-a1ad-2cb8b8fe3296
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2017
Package DI Number
M996CI552
Quantity per Package
10
Contains DI Package
M996CI550
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |