AMSafe® I.V. Administration Set - AMSafe® I.V. Administration Set89" (226 cm) 60 - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSafe® I.V. Administration Set89" (226 cm) 60 Drop Non-Vented Gravity Admin Set with Pre- AMSafe® I.V. Administration Set89" (226 cm) 60 Drop Non-Vented Gravity Admin Set with Pre-Slit Port, MicroClave® Clear, 1 Ext. Set, Pinch Clamp, Rotating Male Luer Lock. Approx. Priming Volume: 18mL

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

MR6083-05

Brand Name

AMSafe® I.V. Administration Set

Version/Model Number

1

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)

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

4667d4b9-a0c6-4b63-ac52-0023861af22e

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

40704411005170

Quantity per Package

50

Contains DI Package

10704411005179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"AMSINO INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 89
2 A medical device with a moderate to high risk that requires special controls. 411
U Unclassified 1