TruSignal SpO2 - Replacement Tape Blue for TruSignal AllFit - GE MEDICAL SYSTEMS, INC.

Duns Number:809785715

Device Description: Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs

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More Product Details

Catalog Number

TS-RT-100

Brand Name

TruSignal SpO2

Version/Model Number

TS-RT-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040831

Product Code Details

Product Code

DPZ

Product Code Name

Oximeter, ear

Device Record Status

Public Device Record Key

89b376ba-d7db-4c0f-b5b6-2ef8e1adfb14

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 54