ROM Plus®, Fetal Membranes Rupture Test

GUDID 10814247020434

ROM Plus® Complete Kit Fetal Membranes Rupture Test

CLINICAL INNOVATIONS, LLC

Amniotic fluid leak detection device

• Primary Device ID: 10814247020434
• NIH Device Record Key: 64c9e25d-ce8f-4194-86f8-d48976cff5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROM Plus®, Fetal Membranes Rupture Test
• Version Model Number: ROM-5025
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020437 [Primary]
GS1	10814247020434 [Package]; Contains: 00814247020437; Package: [25 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

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

• 10814247020434: ROM Plus® Complete Kit Fetal Membranes Rupture Test
• 20814247020424: ROM Plus® Complete Test Kit
• 00814247020406: ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test