FDA.reportPublic FDA data

ROM Plus®, Fetal Membranes Rupture Test

Primary DI
00814247020437
Brand
ROM Plus®, Fetal Membranes Rupture Test
Company
CLINICAL INNOVATIONS, LLC
Model
ROM-5025
Device description
ROM Plus® Complete Kit Fetal Membranes Rupture Test
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
CodeName
NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110605000ROM PLUSClinical Innovations, LLC2011-11-23NQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814247020434PackageGS125In Commercial Distribution
00814247020437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081424702043410814247020434
00814247020437008142470204378142470204370814247020437

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic fluid leak detection device IVDAn 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
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place. Do not freeze.
Storage Environment Temperature4 Degrees Celsius24 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814247021304Panniculus Retraction KitPRS-CK-05SM2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallPRS-CK-05MD2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargePRS-CK-05LG2026-05-31
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
00814247020369traxi® Panniculus Retractor ExtenderPRS-10502016-09-01
30814247020346traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetaiPRS-05302016-09-01
30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
00814247020802traxi® Panniculus RetractorPRS-EVAL2016-09-22
00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
00814247020178Koala®IPC-5000E2016-09-01
00814247020741Goldtrace OneCNS0000082016-09-01
00814247020505Spiral Fetal Scalp ElectrodeCNS0000042016-09-01
00814247020512FSE CablesSBT-70102016-09-01
00814247020529FSE CablesSBT-70112016-09-01
00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247020857ROM Plus, Quality Control for Fetal Membranes Rupture TesCLINICAL INNOVATIONS, LLCNQM2016-09-23
00814247020895ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
00814247020925ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
00814247020956ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
10814247020854ROM Plus, Quality Control for Fetal Membranes Rupture TesCLINICAL INNOVATIONS, LLCNQM2016-09-23
00814247020864ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
10814247020892ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
10814247020922ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
10814247020953ROM Plus, Complete Kit Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-23
00814247020420ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-01
00814247020444ROM Plus®, Fetal Membranes Rupture Collection KitCLINICAL INNOVATIONS, LLCNQM2016-09-01
00814247020406ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-01
20814247020424ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-01
10814247020434ROM Plus®, Fetal Membranes Rupture TestCLINICAL INNOVATIONS, LLCNQM2016-09-01
20814247020448ROM Plus®, Fetal Membranes Rupture Collection KitCLINICAL INNOVATIONS, LLCNQM2016-09-01