ROM Plus® Quality Control Kit

GUDID 20814247020455

ROM Plus®, Quality Control for Fetal Membranes Rupture Test

CLINICAL INNOVATIONS, LLC

Amniotic fluid leak detection device Amniotic fluid leak detection device

• Primary Device ID: 20814247020455
• NIH Device Record Key: 1f468120-4ee1-4ffc-80e6-7c3bfbeb83c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROM Plus® Quality Control Kit
• Version Model Number: ROM-QC
• 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	00814247020451 [Primary]
GS1	10814247020458 [Package]; Contains: 00814247020451; Package: [5 Units]; In Commercial Distribution
GS1	20814247020455 [Package]; Contains: 10814247020458; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110605

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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

Devices Manufactured by CLINICAL INNOVATIONS, LLC

• 10814247021196 - FSE: 2023-10-05 Fetal Spiral Electrode
• 00814247021205 - FSE Cables: 2023-10-05 DECG Reusable Legplate Adapter Cable
• 10814247020120 - babyLance: 2023-04-24 Preemie (Pink/White) 0.85 mm depth, Safety Heelstick
• 10814247020168 - babyLance: 2023-04-24 Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick
• 10814247020182 - babyLance: 2023-04-24 Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick
• 10814247021127 - ABBy: 2023-04-24 ABBy Panniculus Retractor - 05 Regular
• 10814247021134 - ABBy: 2023-04-24 ABBy Panniculus Retractor - 05 Extra Large
• 10814247021141 - ABBy: 2023-04-24 ABBy Panniculus Retractor - 10 Regular