Duns Number:604208868
Device Description: #1661 Cricothyrotomy Kit 6.0mmContents: (1) E.T. Tube 6.0mm, (1) Inflation Syringe 10mL, ( #1661 Cricothyrotomy Kit 6.0mmContents: (1) E.T. Tube 6.0mm, (1) Inflation Syringe 10mL, (1) PVP Prep Pad, (1) Earloop Mask / Face Shield, (1) Scalpel #10, (1) Sponge 4x4 2/Pk, (1) Tracheal Retractor, (1) Tracheal Dilator, (1) ICON Stabilization Device w/Instruction Sheet
Catalog Number
1661
Brand Name
Motion Medical Distributing
Version/Model Number
1661
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
c93b02ce-a83e-4e42-b30f-e0a94f8727e4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 2016
Package DI Number
25060498450090
Quantity per Package
10
Contains DI Package
15060498450093
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |