FDA.reportPublic FDA data

Schiller temperature sensor connecting cable

Primary DI
07613365003833
Brand
Schiller temperature sensor connecting cable
Company
Schiller AG
Model
2.310262
Catalog number
2.310262
Device description
Temp LP 3.0 Mallinckrodt CC
Published
2023-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221056000ARGUS PB-3000Schiller AG2023-07-06MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365003833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365003833076133650038337613365003833

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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 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

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