TruSignal SpO2 TS-RWL-24

GUDID 00840682147255

Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs

GE MEDICAL SYSTEMS, INC.

Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable

• Primary Device ID: 00840682147255
• NIH Device Record Key: 375c6053-254b-4e77-baea-149c48d37dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruSignal SpO2
• Version Model Number: TS-RWL-24
• Catalog Number: TS-RWL-24
• 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	00840682147255 [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
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• 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