MEDRAD® Veris™ 8600 Vital Signs Monitor 3010534

GUDID 10616258009435

"Pediatric Blood Pressure Disposable Cuffs 3-6in (8-15 cm) (BP CUFF, DISP, 8-15CM, VERIS,MC) (85276697)"

BAYER MEDICAL CARE INC.

Blood pressure cuff, single-use

• Primary Device ID: 10616258009435
• NIH Device Record Key: 6ba57ca8-519f-496e-adb9-559151f7b9e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Veris™ 8600 Vital Signs Monitor
• Version Model Number: 3010534
• Catalog Number: 3010534
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• 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: 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

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258009438 [Primary]
GS1	10616258009435 [Package]; Contains: 00616258009438; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042569

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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: 2017-06-23

On-Brand Devices [MEDRAD® Veris™ 8600 Vital Signs Monitor]

• 00616258009643: "PROBE, TEMPERATURE, SKIN (PROBE, TEMPERATURE, SKIN) (85276514)"
• 00616258009636: "PROBE, PULSE OX, GRIP, SMALL, 2M, VERIS (ASSY,PULSE OX,GRIP,SMALL,2M,VERIS,MC) (60764741)"
• 00616258009629: "PROBE, PULSE OX, GRIP, MEDIUM, 2M, VERIS (ASSEMBLY,PULSE OX GRIP,MEDIUM,VERIS,MC) (60764733)"
• 00616258009612: "PROBE, PULSE OX, GRIP, LARGE, 2M, VERIS (ASSY,PULSE OXIMETER,GRIP,LRG,2M,VERIS,MC) (60764725)"
• 00616258009605: "PROBE,PULSE OXIMETER, PEDIATRIC,2M,VERIS (ASSY, PULSE OXIMETER PROBE, PEDIATRIC,MC) (60764539)"
• 00616258009599: "BP CUFF,THIGH,44-66cm,VERIS (BP CUFF,THIGH,44-66CM,VERIS, MC) (85278282)"
• 00616258009582: BP CUFF,LARGE ARM,33-47cm, VERIS (BP CUFF,LLARGE ARM,33-47CM, VERIS, MC) (85278207)
• 00616258009575: BP CUFF, PED/SMALL ADULT,18-26cm,VERIS (BP CUFF, PED/SMALL ADULT,18-26CM,VERIS, MC) (85278177)
• 00616258009568: "BP CUFF, ADULT, 25-35cm, VERIS (NIBP Cuff (25-35cm), Adult, MR Compatible, MC) (85278185)"
• 00616258009551: "PROBE, PULSE OXIMETER, ADULT, 2M, VERIS (ASSY, PULSE OXIMETER PROBE, ADULT,MC) (60764377)"
• 10616258009541: Adult Blood Pressure Disposable Cuffs 9-13 in (23-33 cm) (BP CUFF,DISP,22-32 CM, VERIS,MC) (8527
• 10616258009534: "Pediatric Blood Pressure Disposable Cuffs 7-10 in (17-25 cm) (BP CUFF,DISP,17-25CM,VERIS BX QTY
• 10616258009527: "Adult Blood Pressure Disposable Cuffs 14.5-19 in (37-48.5 cm) (BP CUFF, DISP, 37-49CM, VERIS,MC
• 10616258009510: "Adult Blood Pressure Disposable Cuffs 12-15.5 in (30.5-39.5 cm) (BP CUFF,DISP,30-40CM,VERIS,MC)
• 10616258009503: " Veris Water Trap 30/Box (WATER TRAP, BOX OF 30, VERIS,MC) (85264559)"
• 10616258009497: " Veris Cannula, Nasal, Pediatric, 10 ea (CANNULA, NASAL, DISP, PED, QTY 10,MC) (85281917)"
• 00616258009483: " Veris Cannula, Nasal, Adult, 10 ea (CANNULA, NASAL, DISP, ADULT,QTY 10,MC) (85281909)"
• 10616258009473: " Veris Cannula, Nasal, Divided, Adult, 10 ea (CANNULA,NASAL,DIV,DISP,ADLT,QTY10,MC) (85281968)"
• 10616258009466: " Veris Cannula, Nasal, Divided, Pediatric, 10ea (CANNULA,NASAL,DIVIDED,DISP,PED,QTY10,MC) (8528
• 10616258009459: " Veris Sample lines, 16ft.(5 m), 25 ea (SAMPLE LINES, 16 FT., BOX QTY. 25,MC) (85276727)"
• 10616258009442: "Pediatric Blood Pressure Disposable Cuffs 4-7.5 in (10-19 cm) (BP CUFF, DISP, 10-19CM,VERIS,M
• 10616258009435: "Pediatric Blood Pressure Disposable Cuffs 3-6in (8-15 cm) (BP CUFF, DISP, 8-15CM, VERIS,MC) (
• 10616258009428: "Pediatric Blood Pressure Disposable Cuffs 2.75-5in (7-13 cm) (BP CUFF, DISP, 7-13CM, VERIS,MC
• 10616258009411: "Pediatric Blood Pressure Disposable Cuffs 2-4.25in (6-11 cm) (BP CUFF, DISP, 6-11CM, VERIS,MC)
• 10616258009404: "Pediatric Blood Pressure Disposable Cuffs 1.5-3in (4-8 cm) (BP CUFF, DISP, 4-8CM, VERIS,MC) (85
• 10616258009398: "Pediatric Blood Pressure Disposable Cuffs 1-2in (3-6 cm) (BP CUFF, DISP, 3-6CM, VERIS,MC) (8527