Duns Number:316584937
Device Description: Equipped with an extremely low-level, easy-access platform, a stable handrail, and high we Equipped with an extremely low-level, easy-access platform, a stable handrail, and high weight-bearing capacity, this multifunctional scale ensures safe and comfortable weighing of heavy patients. The integrated handrail provides the patient with support throughout the weighing process – or sat on a chair placed on the generous platform. The Pre-TARE function with three memory cells automatically deducts a stored weight (such as a chair) to determine net weight. Moreover, the seca 644 is made mobile by two rubber wheels and a power supply provided by rechargeable batteries or power adapter.
Catalog Number
6441321108
Brand Name
seca 644
Version/Model Number
644
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
0648d584-df90-48ec-9a73-749b88a12941
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
August 15, 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 |