TruSignal SpO2

Basic Information

• Brand Name: TruSignal SpO2
• Primary DI: 00840682147316
• Version / Model: TS-RT-100
• Catalog Number: TS-RT-100
• Company Name: GE MEDICAL SYSTEMS, INC.
• Labeler DUNS: 809785715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-03
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 89b376ba-d7db-4c0f-b5b6-2ef8e1adfb14

Device Description

Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPZ	Oximeter, ear	Cardiovascular	870.2710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) 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 might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682147316	GS1

Premarket Submissions

Submission Number	Supplement Number
K040831	000