FDA.reportPublic FDA data

Sechrist Industries, Inc.

Primary DI
00899660002901
Brand
Sechrist Industries, Inc.
Company
SECHRIST INDUSTRIES, INC.
Model
22191-1
Device description
CABLE ASSY. RDMTR INTERIOR
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKDMonitor, Carbon-Dioxide, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905225000HBO CABLE ASSEMBLY, RADIOMETER TC-02Sechrist1991-04-10LKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899660002901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899660002901008996600029018996600029010899660002901

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7145798400productinformation@sechristusa.com

Regulatory Flags#

DUNS number
062084215
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073470091Sechrist Industries, Inc.21709-00U2026-01-27
00850073470084Sechrist Industries, Inc.218812025-10-02
00850073470015Sechrist Industries, Inc.20582-0212025-04-23
00850073470022Sechrist Industries, Inc.20582-S-3112025-04-23
00850073470039Sechrist Industries, Inc.20582-S-2312025-04-23
00850073470046Sechrist Industries, Inc.20582-021-282025-04-23
00899660002253Sechrist Industries, Inc.21762-010-36H2016-12-12
00899660002260Sechrist Industries, Inc.21762-0112016-12-12
00899660002277Sechrist Industries, Inc.21762-1102016-12-12
00899660002284Sechrist Industries, Inc.21762-110-33H2016-12-12
00899660002291Sechrist Industries, Inc.21762-110-36H2016-12-12
00899660002307Sechrist Industries, Inc.21762-110-41H2016-12-12
00899660002314Sechrist Industries, Inc.21762-111-36H2016-12-12
00899660002321Sechrist Industries, Inc.21762-1242016-12-12
00852682007064Sechrist Industries, Inc.21762-1112016-12-12
00899660002000Sechrist Industries, Inc.3300H-H-01-12017-06-02
00899660002017Sechrist Industries, Inc.3300H-00-02016-12-12
00899660002024Sechrist Industries, Inc.3300H-00-12016-12-12
00899660002031Sechrist Industries, Inc.3300H-01-12016-12-12
00899660002048Sechrist Industries, Inc.3300HR-00-12016-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSLKD2025-04-23
07640121880988103149 Calibration GasSenTec AGLKD2024-07-05
07640121880995103164 tCOM+SenTec AGLKD2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGLKD2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGLKD2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGLKD2024-07-05
00899660002895Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.LKD2023-08-01
00899660002918Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.LKD2023-08-01
07640121881039Non-Adhesive WrapSenTec AGLKD2023-07-21
07640121880964Patient Application Kit for mature intact skinSenTec AGLKD2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGLKD2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGLKD2021-09-26
07640121880889SDM Water Protection CoverSenTec AGLKD2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGLKD2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGLKD2021-02-28
07640121880810Ear Clip easySenTec AGLKD2020-03-31
07640121880858Contact Gel 2mlSenTec AGLKD2019-03-08
17640121880862Contact GelSenTec AGLKD2019-03-05
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinSenTec AGLKD2019-01-29
07640121880797Multi-Site Attachment Ring for mature/intact skinSenTec AGLKD2019-01-29
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHLKD2018-12-18
07640121880315PSG-XSenTec AGLKD2018-11-12
07640121880612PSG Cable ASenTec AGLKD2018-11-12
07640121880629PSG Cable BSenTec AGLKD2018-11-12
07640121880636PSG Cable CSenTec AGLKD2018-11-12
07640121880643PSG Cable DSenTec AGLKD2018-11-12
07640121880650PSG Cable ESenTec AGLKD2018-11-12
07640121880667PSG Cable FSenTec AGLKD2018-11-12
07640121880674PSG Cable GSenTec AGLKD2018-11-12
07640121880681PSG Cable HSenTec AGLKD2018-11-12