Home GUDID 00814247020420 ROM Plus®, Fetal Membranes Rupture Test
Primary DI 00814247020420
Brand ROM Plus®, Fetal Membranes Rupture Test
Company CLINICAL INNOVATIONS, LLC
Model ROM-5000
Device description ROM Plus® Complete Test Kit
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
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 10814247020427 Package GS1 5 In Commercial Distribution 20814247020424 Package GS1 4 In Commercial Distribution 00814247020420 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 10814247020427 10814247020427 20814247020424 20814247020424 00814247020420 00814247020420 814247020420 0814247020420
GMDN Terms# Term, Definition table Term Definition Amniotic fluid leak detection device IVD An in vitro diagnostic 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry place. Do not freeze. Storage Environment Temperature 4 Degrees Celsius 24 Degrees Celsius
Regulatory Flags# DUNS number 809524291 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true 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 10814247020892 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 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