Duns Number:621904622
Device Description: The TMK-IV/IO is designed to conveniently house essential intravenous (IV) and intraosseou The TMK-IV/IO is designed to conveniently house essential intravenous (IV) and intraosseous (IO) infusion supplies and medications for tactical missions.
Catalog Number
01323REF
Brand Name
Intravenous-Intraosseous Kit (TMK-IV/IO), Refill, Contents Only
Version/Model Number
01323REF
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
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
7fa203fb-f131-40c2-8d29-cfe2ac7e2409
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 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 |