Duns Number:621904622
Device Description: The TMM-BCR-SOF contains the necessary items to establish a surgical airway with a Bougie The TMM-BCR-SOF contains the necessary items to establish a surgical airway with a Bougie tube introducer when other methods are unsuccessful, as requested by the U.S. Millitary.
Catalog Number
02923
Brand Name
TMM-BCR-SOF, Tactical Medical Module- Bougie Assisted Cricothyrotomy-SOF
Version/Model Number
02923
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
51ed8eae-40e7-4062-906d-ef6e6bf9da5c
Public Version Date
May 21, 2020
Public Version Number
1
DI Record Publish Date
May 13, 2020
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 |