TruSignal SpO2 TS-RTB-100

GUDID 00840682147262

Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs

GE MEDICAL SYSTEMS, INC.

Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone

• Primary Device ID: 00840682147262
• NIH Device Record Key: 10ce51a3-6baa-4b1b-a9a2-f9133392d1e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruSignal SpO2
• Version Model Number: TS-RTB-100
• Catalog Number: TS-RTB-100
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682147262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040831

FDA Product Code

• DPZ: Oximeter, ear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [TruSignal SpO2]

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• 00840682147309: Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs
• 00840682147293: Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs
• 00840682147286: Replacement Headband for TruSignal Ear sensor, 3 pcs
• 00840682147279: Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs
• 00840682147262: Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs
• 00840682147255: Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs
• 00840682147248: Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs