FDA.reportPublic FDA data

TruSignal SpO2

Primary DI
00840682147262
Brand
TruSignal SpO2
Company
GE MEDICAL SYSTEMS, INC.
Model
TS-RTB-100
Catalog number
TS-RTB-100
Device description
Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs
Published
2021-09-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPZOximeter, ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040831000DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.2004-09-02DPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682147262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682147262008406821472628406821472620840682147262

GMDN Terms#

Term, Definition table
TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809785715
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682147316TruSignal SpO2TS-RT-100TS-RT-1002021-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDPZ2026-04-15
00195278984784TruSignal SpO2GE Healthcare Finland OyDPZ2025-06-16
00860008683236OxiWearOXIWEAR, INC.DPZ2025-06-04
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSDPZ2025-04-23
07640121880988103149 Calibration GasSenTec AGDPZ2024-07-05
07640121880995103164 tCOM+SenTec AGDPZ2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDPZ2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGDPZ2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGDPZ2024-07-05
00195278561312Portrait VSMGe Medical Systems Information Technologies, Inc.DPZ2024-05-05
07640121881039Non-Adhesive WrapSenTec AGDPZ2023-07-21
17640121881036Non-Adhesive WrapSenTec AGDPZ2023-07-21
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDPZ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDPZ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDPZ2023-04-19
00195278524089NAGE Healthcare Finland OyDPZ2023-04-19
00195278288639CARESCAPE ONEGe Medical Systems Information Technologies, Inc.DPZ2022-05-13
00840682146111CARESCAPE B650GE Healthcare Finland OyDPZ2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyDPZ2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyDPZ2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
07640121880964Patient Application Kit for mature intact skinSenTec AGDPZ2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGDPZ2021-09-26
17640121880978Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
00840682147248TruSignal SpO2GE Healthcare Finland OyDPZ2021-09-03