ROM Plus, Complete Kit Fetal Membranes Rupture Test

GUDID 10814247020892

ROM Plus Lab Correlation Kit

CLINICAL INNOVATIONS, LLC

Amniotic fluid leak detection device

• Primary Device ID: 10814247020892
• NIH Device Record Key: d4148eae-fcf6-430d-a304-d8e02fbd667a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROM Plus, Complete Kit Fetal Membranes Rupture Test
• Version Model Number: ROM-7065
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020895 [Primary]
GS1	10814247020892 [Package]; Contains: 00814247020895; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110605

FDA Product Code

• NQM: Immunoassay For Detection Of Amniotic Fluid Protein(S).

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ROM Plus, Complete Kit Fetal Membranes Rupture Test]

• 10814247020953: ROM Plus Strip/Collection Kit
• 10814247020922: ROM Plus POC Correlation Kit
• 10814247020892: ROM Plus Lab Correlation Kit
• 00814247020864: ROM Plus Lab Validation Kit