Duns Number:005036025
Device Description: The Midmark 640 Pediatric Exam Table is intended to provide positioning and support of pat The Midmark 640 Pediatric Exam Table is intended to provide positioning and support of patients for general exam procedures conducted by medical professionals. The intended patient weight is to be between 5lbs - 40lbs. The digital scale is intended for regular monitoring to assess patient weight change, as well as to assist medical diagnosis. The manual infantometer is intended for regular monitoring to assess patient length change, as well as to assist medical diagnosis.
Catalog Number
640-002
Brand Name
Midmark
Version/Model Number
640-002
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
a88036b4-616e-4464-a76f-5f5d28bbcf80
Public Version Date
May 05, 2020
Public Version Number
2
DI Record Publish Date
August 16, 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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |