Duns Number:790605856
Device Description: Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Pre-cut. Wa Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Pre-cut. Water-resistant. 1 box= 5 belts. Length = 4 - 1/4' (1.3m) Width = 2" (50mm)
Catalog Number
M1562B
Brand Name
Fetal Measurements
Version/Model Number
REUSABLE ABDOMINAL/LEG BELT- 50MM X 1.3M
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
HGM
Product Code Name
SYSTEM, MONITORING, PERINATAL
Public Device Record Key
65446bf1-50c5-4786-8738-fb2cfaf8eb39
Public Version Date
March 07, 2022
Public Version Number
8
DI Record Publish Date
September 30, 2016
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |