Vital Signs - Vital Signs&#174 Disposable Esophageal - Carefusion Finland 320 Oy

Duns Number:367919120

Device Description: Vital Signs&#174 Disposable Esophageal Stethoscope with Temperature Probe, Non-Sterile, Vital Signs&#174 Disposable Esophageal Stethoscope with Temperature Probe, Non-Sterile, 12FR

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More Product Details

Catalog Number

1010EU

Brand Name

Vital Signs

Version/Model Number

1010EU

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"

Yes

For Single-Use

Yes

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

0554e677-d666-4637-8d24-f215866fe603

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50885403288249

Quantity per Package

50

Contains DI Package

10885403288241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CAREFUSION FINLAND 320 OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 363