Duns Number:809524291
Device Description: ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
Catalog Number
-
Brand Name
ROM Plus®, Fetal Membranes Rupture Test
Version/Model Number
ROM-1025
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"
Yes
For Single-Use
Yes
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
K110605,K110605,K110605
Product Code
NQM
Product Code Name
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Public Device Record Key
99f21712-c235-416e-bc22-0059560a86d2
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
10814247020403
Quantity per Package
25
Contains DI Package
00814247020406
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |