A2000 Multi-use Syringe Kit - A2000 Multi-use Syringe Kit, p/n 701669-008Kit - ACIST MEDICAL SYSTEMS, INC.

Duns Number:926684994

Device Description: A2000 Multi-use Syringe Kit, p/n 701669-008Kit Contents: 100mL contrast reservoir and tubi A2000 Multi-use Syringe Kit, p/n 701669-008Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps

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More Product Details

Catalog Number

-

Brand Name

A2000 Multi-use Syringe Kit

Version/Model Number

014612

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

K171646,K171646

Product Code Details

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

1ab057f9-dcca-41f3-8aba-912d29700f24

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Additional Identifiers

Package DI Number

30841716102548

Quantity per Package

10

Contains DI Package

10841716102544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box

"ACIST MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 193