Home GUDID 10814247020892 ROM Plus, Complete Kit Fetal Membranes Rupture Test
Primary DI 10814247020892
Brand ROM Plus, Complete Kit Fetal Membranes Rupture Test
Company CLINICAL INNOVATIONS, LLC
Model ROM-7065
Device description ROM Plus Lab Correlation Kit
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NQM Immunoassay For Detection Of Amniotic Fluid Protein(S). Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10814247020892 Package GS1 4 In Commercial Distribution 00814247020895 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10814247020892 10814247020892 00814247020895 00814247020895 814247020895 0814247020895
GMDN Terms# Term, Definition table Term Definition Amniotic fluid leak detection device A device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device.
Regulatory Flags# DUNS number 809524291 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00814247020857 ROM Plus, Quality Control for Fetal Membranes Rupture Tes CLINICAL INNOVATIONS, LLC NQM 2016-09-23 00814247020895 ROM Plus, Complete Kit Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-23 00814247020925 ROM Plus, Complete Kit Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-23 00814247020956 ROM Plus, Complete Kit Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-23 10814247020854 ROM Plus, Quality Control for Fetal Membranes Rupture Tes CLINICAL INNOVATIONS, LLC NQM 2016-09-23 00814247020864 ROM Plus, Complete Kit Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-23 10814247020922 ROM Plus, Complete Kit Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-23 10814247020953 ROM Plus, Complete Kit Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-23 00814247020420 ROM Plus®, Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-01 00814247020437 ROM Plus®, Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-01 00814247020444 ROM Plus®, Fetal Membranes Rupture Collection Kit CLINICAL INNOVATIONS, LLC NQM 2016-09-01 00814247020406 ROM Plus®, Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-01 20814247020424 ROM Plus®, Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-01 10814247020434 ROM Plus®, Fetal Membranes Rupture Test CLINICAL INNOVATIONS, LLC NQM 2016-09-01 20814247020448 ROM Plus®, Fetal Membranes Rupture Collection Kit CLINICAL INNOVATIONS, LLC NQM 2016-09-01