Duns Number:604208868
Device Description: #1620NS Surgical Airway KitContents: (1) ET Tube 6.0mm, (1) Tracheal Retractor 4" NS, (1) #1620NS Surgical Airway KitContents: (1) ET Tube 6.0mm, (1) Tracheal Retractor 4" NS, (1) Syringe 3mL, (1) ET Tube Stabilization Device, (2) Nitrile Glove LG, (1) Scalpel #10, (2) Alcohol Prep Pad
Catalog Number
1620NS
Brand Name
Motion Medical Distributing
Version/Model Number
1620NS
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
e25090ef-0955-4945-9f6a-b6686c9f99dd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 22, 2017
Package DI Number
25060498451332
Quantity per Package
10
Contains DI Package
15060498451335
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |