Duns Number:557821760
Device Description: The Rapid Seal SE470 is a compact and lightweight tube sealer with a hand unit. The device The Rapid Seal SE470 is a compact and lightweight tube sealer with a hand unit. The device is specially designed to seal the cord blood freezing bags and tubing. Long and slim sealing head is suitable for sealing the channels between two compartments of bag.
Catalog Number
SE470
Brand Name
Rapid Seal Tube Sealer SE470
Version/Model Number
SE470
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
8e252f93-2fd4-4f46-870e-018e962e790f
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 |