FDA.reportPublic FDA data

Schiller ECG wire set

Primary DI
07613365000344
Brand
Schiller ECG wire set
Company
Schiller AG
Model
2.410308
Catalog number
2.410308
Device description
PB-X000, LCM, RT, 1.2m
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012226000
K221056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012226000MONITORING SYSTEM,MODEL ARGUS PB-1000Schiller AG2002-04-08MHX
K221056000ARGUS PB-3000Schiller AG2023-07-06MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365000344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365000344076133650003447613365000344

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41417664242info@schiller.ch

Regulatory Flags#

DUNS number
480868538
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613365003925SCHILLERECG D-SUB2 C 4.6/4.25 x10 IEC2.4001842026-05-26
07613365003932SCHILLERECG D-SUB2 C 4.6/4.25 x10 AHA2.4001852026-05-26
07613365003949SCHILLERECG D-SUB2 B 3.1/2.55 x10 IEC2.4001862026-05-26
07613365003956SCHILLERECG D-SUB2 B 3.1/2.55 x10 AHA2.4001872026-05-26
07613365004199SCHILLERECG D-SUB2 C 3.5/3.1 x14 IEC2.4003332026-05-26
07613365004205SCHILLERECG D-SUB2 C 3.5/3.1 x14 AHA2.4003342026-05-26
07613365004212SCHILLERECG D-SUB2 B 3.5/3.1 x14 IEC2.4003352026-05-26
07613365004229SCHILLERECG D-SUB2 B 3.5/3.1 x14 AHA2.4003362026-05-26
07613365004359ARGUS PB-3000PB-3000 Var.10, sub-variant: M/I3.9210332025-08-19
07613365000085ARGUS® PB-10003.9209483.9209482016-09-18
07613365000092ARGUS® PB-10003.9209783.9209782016-09-18
07613365004168ARGUS PB-3000PB-3000 Var.9, sub-variant: LB3.9210322025-08-19
07613365000122SCHILLERBP-200 plus3.9303002023-03-01
07613365000139SCHILLERBP-200 plus3.9303012023-03-01
07613365000245Schiller ECG patient cable2.4001392.4001392023-06-06
07613365002874Schiller ECG patient cable2.4001422.4001422023-06-06
07613365003208Schiller ECG patient cable2.4001402.4001402023-06-06
07613365003215Schiller ECG patient cable2.4001412.4001412023-06-06
07613365002218Schiller ECG patient cable2.4001782.4001782021-11-08
07613365002225Schiller ECG patient cable2.4001792.4001792021-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19