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ROM Plus, Complete Kit Fetal Membranes Rupture Test

FDA UDI

Class I (US FDA UDI)

by Clinical Innovations, LLC

Identity

Trade Name
ROM Plus, Complete Kit Fetal Membranes Rupture Test FDA UDI
Generic Name
Amniotic fluid leak detection device IVD FDA UDI
Device Name
ROM Plus Lab Correlation Kit FDA UDI
Model / Reference
ROM-7065 FDA UDI
Description
ROM Plus Lab Correlation Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00814247020895 FDA UDI
510(k) Number
K110605 FDA UDI
FDA Product Code
NQM FDA UDI
GMDN Term
Amniotic fluid leak detection device IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Amniotic fluid leak detection device IVD

ROM Plus, Complete Kit Fetal Membranes Rupture Test by Clinical Innovations, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amniotic fluid leak detection device IVD.

Cleared under the same submission

K110605 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinical Innovations, LLC

Sources (1)

  • FDA UDI d4148eae-fcf6-430d-a304-d8e02fbd667a 34 fields · synced Jun 9, 2026