Duns Number:316584937
Device Description: With its high capacity of 360 kg, this scale makes it easy to weigh even heavy patients. E With its high capacity of 360 kg, this scale makes it easy to weigh even heavy patients. Easy access is assured by its extremely low platform. The secure side rails give additional safety. An integrated Pre-TARE function determines in seconds the net weight of the patient by utilizing internal weight memory.
Catalog Number
6641321103
Brand Name
seca 664
Version/Model Number
664
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
INF
Product Code Name
SCALE, PLATFORM, WHEELCHAIR
Public Device Record Key
c4025570-703b-4df5-ba90-89ff82c0155e
Public Version Date
September 17, 2018
Public Version Number
1
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 |