Duns Number:316584937
Device Description: With the Interface Module seca 452 seca scales can be refitted with minimum expense and ef With the Interface Module seca 452 seca scales can be refitted with minimum expense and effort to make them fully integrated via seca software. The module can be installed in a easy-to-assemble holder directly on the product and then configured via the central server. LEDs indicate readiness for use, give the user feedback on the scanned patient barcode and confirm successful transmission of measurements to the electronic medical record system.
Catalog Number
4520050009
Brand Name
seca 452
Version/Model Number
452
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
OUG
Product Code Name
Medical device data system
Public Device Record Key
473c5f9c-f3d2-446f-8d1b-213138b74ec6
Public Version Date
January 18, 2019
Public Version Number
1
DI Record Publish Date
December 18, 2018
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| U | Unclassified | 3 |