Duns Number:557821760
Device Description: The Rapid Seal Tube Sealer SE640 is a lightweight portable sealing device with a hand unit The Rapid Seal Tube Sealer SE640 is a lightweight portable sealing device with a hand unit to seal the blood bag tubing and PVC tubes. The device is powered by a rechargeable battery pack.
Catalog Number
SE640
Brand Name
Rapid Seal Tube Sealer SE640
Version/Model Number
SE640
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"
-
For Single-Use
-
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
KSD
Product Code Name
Device, Heat-Sealing
Public Device Record Key
d72a7722-6441-4c8a-9f39-7c4eea4e6509
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
April 03, 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 | 10 |