Vital Signs™ - Reusable Temperature Probes, 400-Series, General - Vyaire Medical Oy

Duns Number:368457563

Device Description: Reusable Temperature Probes, 400-Series, General Purpose Probe, Pediatric, 3 m/10 ft.

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More Product Details

Catalog Number

M1024251

Brand Name

Vital Signs™

Version/Model Number

M1024251

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

c1663f86-51e3-476c-9996-7b3acf30e3a8

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

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