Duns Number:316584937
Device Description: Battery for mobile use of seca baby scales (seca 7x7, seca 33x i) with EMR connection. sec Battery for mobile use of seca baby scales (seca 7x7, seca 33x i) with EMR connection. seca 454 is supplied with an additional storage compartment for the battery.
Catalog Number
4540010009
Brand Name
seca 454
Version/Model Number
454
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
FRW
Product Code Name
SCALE, PATIENT
Public Device Record Key
aa07c033-2905-4be7-b7c5-5232fe5215f6
Public Version Date
August 08, 2019
Public Version Number
1
DI Record Publish Date
July 31, 2019
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 |