Duns Number:198227881
Device Description: 5127 Bariatric Portable Stand-On Scale with standard weight (lb/kg) (X) and line cord adap 5127 Bariatric Portable Stand-On Scale with standard weight (lb/kg) (X) and line cord adapter IEC Plug Type-B (B)
Catalog Number
5127-X-B
Brand Name
Welch Allyn, Inc.
Version/Model Number
901110
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)
Yes
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
abe27dcd-c73a-4960-852d-e0fb0999a2d5
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
June 26, 2020
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |