FDA.reportPublic FDA data

Reavillmed, LLC

Primary DI
00863523000304
Brand
Reavillmed, LLC
Company
REAVILLMED, LLC
Model
660925B
Published
2016-12-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRSTransducer, Blood-Pressure, Extravascular
LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101189000REAVILLMED PRESSURE MONITORING SYSTEM AND PICCReavillmed2010-12-22DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863523000304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863523000304008635230003048635230003040863523000304

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure monitoring tubing setA collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806747155
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403531722Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531814FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531821FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531913FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531920FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531937FloTracBecton, Dickinson And CompanyDRS2026-09-04
10801902225631ARROWTELEFLEX INCORPORATEDLJS2026-08-18
00885403531845FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403541974FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
10801902192025ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902194364ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902213188ARROWTELEFLEX INCORPORATEDLJS2026-07-23
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
00885403531654Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
00885403531678Acumen IQ, VAMPBecton, Dickinson And CompanyDRS2026-05-30
00885403531739Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00860002238500Piccolo MedicalPiccolo Medical, Inc.LJS2026-05-06
00884908185386Vascu-PICC®Medical Components, Inc.LJS2025-11-20