Duns Number:621904622
Device Description: Chinook designed TMM-PPE Kit, Advanced (Tactical Medical Module-Personal Protective Equipm Chinook designed TMM-PPE Kit, Advanced (Tactical Medical Module-Personal Protective Equipment Kit, Advanced) with clothing and gear to provide barriers between you and a patient thus helping to prevent the spread of infection or illness. This kit contains the essential items necessary to protect your hands, clothes, face and lungs from splattered body fluids and airborne particles.
Catalog Number
01457
Brand Name
TMM-PPE, Advanced
Version/Model Number
01457
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
1afd06a9-edda-44e2-a355-7a38d6bd41bf
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
June 27, 2019
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |