Duns Number:604208868
Device Description: #1677 Cricothyrotomy KitContents: (1) E.T. Tube 6.0mm, (1) Inflation Syringe 10mL, (1) Sca #1677 Cricothyrotomy KitContents: (1) E.T. Tube 6.0mm, (1) Inflation Syringe 10mL, (1) Scalpel #10, (1) Hemostat, (1) Tracheal Retractor
Catalog Number
1677
Brand Name
Motion Medical Distributing
Version/Model Number
1677
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
OGP
Product Code Name
Cricothyrotomy Kit
Public Device Record Key
9f7ce0ed-5fe7-4b23-af37-3cb1ca6bbcfd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |