FDA.reportPublic FDA data

Bio Protech

Primary DI
00817120021125
Brand
Bio Protech
Company
BIO PROTECH USA, INC.
Model
MF2409 (Lifelines)
Device description
MF2409 (Lifelines) - Lifelines OEM, Surface Electrodes, Ring Electrode, PET Film Backing Material, 8x107mm, Hydrogel, 10 pcs per pack, 100 pcs per box, 1,000 pcs per case
Published
2017-08-09
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
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153019000Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc.2016-03-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817120021122PackageGS110In Commercial Distribution
20817120021129PackageGS110In Commercial Distribution
00817120021125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002112210817120021122
2081712002112920817120021129
00817120021125008171200211258171200211250817120021125

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular transmission motion sensorA non-sterile device intended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation. The device, also known as a mechanosensor, is a piezoelectric sensor that functions with an NMT sensor cable and skin surface NMT electrodes to transmit electrical signals to a patient monitoring module dedicated to the monitoring of patient relaxation to determine level of neuromuscular block. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-464-1464support@bioprotechusa.com

Regulatory Flags#

DUNS number
789127011
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817120020609BLUE HAND03RD XTFA2026-07-07
00817120021460BLUE HAND1515SQ XTFO2026-07-07
00817120021477BLUE HAND1.5RD XTFO2026-07-07
00817120021484BLUE HAND02RD XTFO2026-07-07
00817120021491BLUE HAND22SQ XTFO2026-07-07
00817120021507BLUE HAND24RT XTFO2026-07-07
00817120021514BLUE HAND03RD XTFO2026-07-07
00817120020067BLUE HAND1515SQ XTFA2026-07-07
00817120020050Bio Protech48482026-05-07
00817120020043Bio Protech48482016-06-15
00817120020340Bio Protech4848WCBZGN(NST)2016-06-21
00817120021088Bio ProtechSG15R (Lifelines)2017-08-09
00817120021095Bio ProtechSG15G (Lifelines)2017-08-09
00817120021101Bio ProtechNCS-1334 (Lifelines)2017-08-09
00817120021118Bio ProtechNCS-SG15 (Lifelines)2017-08-09
00817120020005Bio Protech MaxTens 1k 2016-06-15
00817120020074Bio ProtechMaxEMS 1k2016-06-16
00817120020081Bio Protech MaxEMS 2k2016-06-17
00817120020562Bio Protech MaxTens 1k Unit2016-09-01
00817120020036Bio Protech MaxTens 2k 2016-06-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00382830063821NatusXLTEKGXY2026-10-15
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00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16