ROM Plus®, Fetal Membranes Rupture Collection Kit

GUDID 20814247020448

ROM Plus® Complete Kit Fetal Membranes Rupture Test

CLINICAL INNOVATIONS, LLC

Amniotic fluid leak detection device

• Primary Device ID: 20814247020448
• NIH Device Record Key: 6827cb7f-acc1-4420-bbbb-f4b8048f5064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROM Plus®, Fetal Membranes Rupture Collection Kit
• Version Model Number: ROM-6000
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place. Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020444 [Primary]
GS1	10814247020441 [Package]; Contains: 00814247020444; Package: [25 Units]; In Commercial Distribution
GS1	20814247020448 [Package]; Contains: 10814247020441; 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: 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