Acta Medical - IV Admin Set 2 NF Y Sites, Backcheck Valve, .22 m - Acta Medical LLC

Duns Number:117299766

Device Description: IV Admin Set 2 NF Y Sites, Backcheck Valve, .22 m filter

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More Product Details

Catalog Number

-

Brand Name

Acta Medical

Version/Model Number

AMBFL0013

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"

Yes

For Single-Use

Yes

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

9091a008-f93a-41ea-bee5-a1367ad575ca

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACTA MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33