Capsule Vitals Plus - Vitals Plus Backpack Oximeter Masimo Thermometer - CAPSULE TECHNOLOGIE

Duns Number:536805245

Device Description: Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo

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More Product Details

Catalog Number

-

Brand Name

Capsule Vitals Plus

Version/Model Number

CAP-VP-NIBPAH-MON-HW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K210204

Product Code Details

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device Record Status

Public Device Record Key

ee730546-9d47-4b6b-b548-d79b3eda0cf7

Public Version Date

March 10, 2022

Public Version Number

1

DI Record Publish Date

March 02, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAPSULE TECHNOLOGIE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 237