TruSignal SpO2 TS-RWL-24

GUDID 00840682147255

Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs

GE MEDICAL SYSTEMS, INC.

Electrode/transducer strap, reusable
Primary Device ID00840682147255
NIH Device Record Key375c6053-254b-4e77-baea-149c48d37dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruSignal SpO2
Version Model NumberTS-RWL-24
Catalog NumberTS-RWL-24
Company DUNS809785715
Company NameGE MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682147255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPZOximeter, ear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-13
Device Publish Date2021-09-03

On-Brand Devices [TruSignal SpO2]

00840682147316Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs
00840682147309Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs
00840682147293Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs
00840682147286Replacement Headband for TruSignal Ear sensor, 3 pcs
00840682147279Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs
00840682147262Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs
00840682147255Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs
00840682147248Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs

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