Volara System - VOLARA, AC NA - HILL-ROM SERVICES PTE. LTD.

Duns Number:595156263

Device Description: VOLARA, AC NA

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More Product Details

Catalog Number

-

Brand Name

Volara System

Version/Model Number

M08573

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)

-

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

NHJ

Product Code Name

DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Device Record Status

Public Device Record Key

5ea2baad-f317-4c47-a2ed-e0f21cf2acca

Public Version Date

May 22, 2020

Public Version Number

1

DI Record Publish Date

May 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HILL-ROM SERVICES PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 131