Duns Number:316584937
Device Description: The seca mechanical baby scale is mainly used in hospitals, doctors' surgeries and inpatie The seca mechanical baby scale is mainly used in hospitals, doctors' surgeries and inpatient care facilities in accordance with national regulations. The scale is both for determining birth weight andchecking weight gain during the growth process, and it supports the doctor supervising treatment in making a diagnosis or deciding on a treatment. In order to make a precise diagnosis, however, otherspecific examinations must be set up by the physician in addition to determination of weight and their results taken into account.
Catalog Number
7251021004
Brand Name
seca 725
Version/Model Number
725
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
FRI
Product Code Name
SCALE, STAND-ON, PATIENT
Public Device Record Key
de528e94-08f5-4820-acfc-4391b40cd2b3
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 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 |