Iradimed 3865

GUDID 00856038001096

MRIDIUM 3865 REMOTE MONITOR

IRADIMED CORP.

Infusion pump remote control

• Primary Device ID: 00856038001096
• NIH Device Record Key: 94c2cf6a-314b-49d1-aaff-5c16e14159bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iradimed
• Version Model Number: 3865
• Catalog Number: 3865
• Company DUNS: 170301969
• Company Name: IRADIMED CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856038001096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090087

FDA Product Code

• LDR: Controller, Infusion, Intravascular, Electronic

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: 2016-08-25

On-Brand Devices [Iradimed]

• 00856038001775: Cuff, NIBP, Adult Long Reuseable (27-35 cm)
• 00856038001706: Adaptor, Anesthesia Airway
• 00856038001690: Scavenge Hose
• 00856038001683: SpO2 Grip Sensor Starter Pack
• 00856038001676: Mount, Arm, 3880 Monitor
• 00856038001669: Mount, Arm, 3886 Agents Module
• 00856038001652: ECG disposable electrode (5 lead)
• 00856038001645: Printer Paper
• 00856038001638: Hose Assembly, NIBP Swift Connect
• 00856038001621: Pole Mount, Rotating, 3880 Monitor
• 00856038001614: Cannula, Pediatric, Bifurcated
• 00856038001607: Cannula, Adult, Bifurcated
• 00856038001591: Cannula, Oral/Nasal Pediatric
• 00856038001584: Cannula, Oral, Adult
• 00856038001577: Cannula, Pediatric
• 00856038001560: Cannula, Infant, Neonatal
• 00856038001553: Cannula, Adult
• 00856038001546: Temperature Sensor, Fiber Optic
• 00856038001539: Cuff, NIBP, Neonatal Size 4 (7-13 cm)
• 00856038001522: Cuff, NIBP, Neonatal size 3 (6-11 cm)
• 00856038001515: Cuff, NIBP, Neonatal Size 2 (4-8 cm)
• 00856038001508: Cuff, NIBP, Neonatal Size 1 (3-6 cm)
• 00856038001492: Cuff, NIBP, Infant Reusable (9-15 cm)
• 00856038001485: Cuff, NIBP, Pediatric Reusable (14-21.5 cm)
• 00856038001478: Cuff, NIBP, Small Adult Reusable (20.5-28.5 cm)
• 00856038001461: Cuff, NIBP, Adult Reusable (27-35 cm)
• 00856038001454: Cuff, NIBP, Large Adult, Reusable (34-44 cm)
• 00856038001447: Sample line EtCO2, w/filter
• 00856038001430: SpO2 Disposable Applicator, Neonatal
• 00856038001423: SpO2 Disposable Applicator, Pediatric
• 00856038001416: SpO2 Disposable Applicator, Infant
• 00856038001409: SpO2 Disposable Applicator, Adult
• 00856038001393: Dual Radio Module, 2.4 GHz, 3880
• 00856038001386: 3880 Universal Gating Interface w/Cable
• 00856038001348: Cable Set, 5-Lead ECG, ePOD (AAMI)
• 00856038001232: Battery Pack, Removable, 8V, 3885T
• 00856038001225: MRI Wireless Multi-Gas Unit w/O2
• 00856038001218: MRI Monitor Remote Base/Charger
• 00856038001201: MRI Monitor Remote Tablet
• 00856038001195: oPOD, Spo2 Module
• 00856038001188: ePOD, 5 Lead ECG Module
• 00856038001171: 3880 MRI Patient Monitoring System
• 00856038001164: FIBER OPTIC SpO2 CABLE KIT
• 00856038001157: MRIDIUM 3860 DERS LIBRARY KIT
• 00856038001140: MRI COMPATIBLE BATTERY PACK
• 00856038001133: AC POWER CORD, HOSPITAL GRADE, 10.0 FT.
• 00856038001126: CABLE, DC CHARGER, 10 FT.
• 00856038001119: AC POWER CORD, HOSPITAL GRADE, 3.0 FT.
• 00856038001102: EXTERNAL DC POWER/CHARGER, MR IV PUMP
• 00856038001096: MRIDIUM 3865 REMOTE MONITOR