FDA.reportPublic FDA data

Schiller SpO2 connecting cable

Primary DI
07613365000603
Brand
Schiller SpO2 connecting cable
Company
Schiller AG
Model
2.310128
Catalog number
2.310128
Device description
SpO2 connecting cable LP Nellcor 3.0 m
Published
2016-09-22
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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365000603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365000603076133650006037613365000603

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
Storage Environment Humidity25 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 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
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
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09
00841034110804ACQUISITION MODULE CABLERPIDSA2016-12-09