Vital Signs™ - Direct Connect Temperature Cable for GE Monitors, - Vyaire Medical Oy

Duns Number:368457563

Device Description: Direct Connect Temperature Cable for GE Monitors, 400 Series, Dual, 3.6 m/12 ft

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More Product Details

Catalog Number

2021704-002

Brand Name

Vital Signs™

Version/Model Number

2021704-002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

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

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

5fac6ebd-7cd9-4d6b-a1c2-e9cd48956e26

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYAIRE MEDICAL OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 600