Catalog Number

-

Brand Name

ROM Plus®, Fetal Membranes Rupture Collection Kit

Version/Model Number

ROM-6000

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

6827cb7f-acc1-4420-bbbb-f4b8048f5064

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020448

Quantity per Package

4

Contains DI Package

10814247020441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-