FDA.reportPublic FDA data

MEDRAD® Veris™ 8600 Vital Signs Monitor

Primary DI
00616258009490
Brand
MEDRAD® Veris™ 8600 Vital Signs Monitor
Company
BAYER MEDICAL CARE INC.
Model
3011507
Catalog number
3011507
Device description
""" Veris Cannula, Nasal, Pediatric, 10 ea(CANNULA, NASAL, DISP, PED, QTY 10,MC)(85281917)"""
Published
2017-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0425690008600 VITAL SIGNS MONITORCriticare Systems, Inc.2004-09-29MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10616258009497PackageGS110In Commercial Distribution
00616258009490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061625800949710616258009497
00616258009490006162580094906162580094900616258009490

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-7231ricustomercomplaints@bayer.com

Regulatory Flags#

DUNS number
058716649
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616258007243200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258007526200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258024325MEDRAD® MRXperion Sterile Disposable MRI KitXP 65/115VSXP 65/115VS2024-05-06
00616258027340Imaging System Interface - ISI2 ModuleISI2ISI22024-06-17
00616258025094MEDRAD® MRXperion MR Injection SystemMRXP 200MRXP 2002024-05-06
00616258026206MEDRAD® MRXperion MR Injection System HandswitchSSMR STARTSSMR START2022-04-22
00616258010090200mL Sterile Disposable Qwik-Fit Syringe & QFT 200-FLS-Q 200-FLS-Q 2019-05-20
00616258005492200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258008165MEDRAD® MRXperion MR Injection SystemSSMR STARTSSMR START2016-09-24
00616258008943MEDRAD® Stellant CT Injection SystemStellant D-CESCT-310, SCT-321, SCT-3222016-09-24
00616258021249MEDRAD® VFLOW Sterile Disposable Hand ControllerVF HCVF HC2025-12-19
00616258020419MEDRAD® Mark 7 Arterion Injection SystemARTERION BASE SYSTEMARTERION BASE SYSTEM2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerVF HCVF HC2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemSCT-310, SCT-321, SCT-322SCT-310, SCT-321, SCT-3222025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationFLEXFLEX2025-12-10
00616258025131MEDRAD® Stellant CT Injection SystemSCT-310, SCT-321, SCT-322SCT-310, SCT-321, SCT-3222024-11-01
00616258010229Avanta Hand Controller SheathAVA 500 HCSAVA 500 HCS2019-05-20
00616258010236Display Control Unit Sheath AVA 500 DCOV AVA 500 DCOV 2019-05-20
00616258021546Avanta Hand Controller SheathAVA 500 HCSAVA 500 HCS2019-10-25
00616258021553Display Control Unit Sheath AVA 500 DCOV AVA 500 DCOV 2019-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.MWI2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08