Procare Spacer chamber Child - ARISE MEDICAL LLC

Duns Number:081149273

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More Product Details

Catalog Number

-

Brand Name

Procare Spacer chamber Child

Version/Model Number

240501

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)

-

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

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Device Record Status

Public Device Record Key

9a7b6614-13cf-41bc-98e6-d0d3d5d4334d

Public Version Date

September 16, 2019

Public Version Number

1

DI Record Publish Date

September 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARISE MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 17