SmartLinx Vitals Plus - Vitals Plus Backpack - CAPSULE TECHNOLOGIE

Duns Number:536805245

Device Description: Vitals Plus Backpack

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More Product Details

Catalog Number

-

Brand Name

SmartLinx Vitals Plus

Version/Model Number

SL-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 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"

-

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

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Device Record Status

Public Device Record Key

8bd4f05c-eb0f-460c-8205-270c67d1b383

Public Version Date

August 14, 2019

Public Version Number

1

DI Record Publish Date

August 06, 2019

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