Duns Number:080361159
Device Description: BAND, FETAL MONITORING BELLY, LARGE, HORIZONTAL STRETCH 14" TO 28", ABDOMINAL CIRCUMFERENC BAND, FETAL MONITORING BELLY, LARGE, HORIZONTAL STRETCH 14" TO 28", ABDOMINAL CIRCUMFERENCE 34" TO 56", BROWN WAISTBAND COLOR, NYLON/SPANDEX, DISPOSABLE, LATEX FREE, 1EA/PK, 50PK/CS
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
1038LG-ASP
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)
Yes
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
ISR
Product Code Name
Band Or Belt, Pelvic Support
Public Device Record Key
eb2c1d6e-f301-43be-9085-a5ae9d2000ed
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |