Ventilator Trolley - Trolley Mounting Bracket, Vivo 50/55/65 - Breas Medical AB

Duns Number:357007657

Device Description: Trolley Mounting Bracket, Vivo 50/55/65

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More Product Details

Catalog Number

007916

Brand Name

Ventilator Trolley

Version/Model Number

007916

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"

-

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

FOX

Product Code Name

Stand, Infusion

Device Record Status

Public Device Record Key

91086d99-42cb-44dd-a4c0-8dd7935ecf8b

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BREAS MEDICAL AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 76