AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber - AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip ChamberNon-Pyroge AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip ChamberNon-Pyrogenic fluid pathway. GRAVITY FEED ONLY. One Split Septum Injection Site. One Rotating Male Luer Lock Adapter. One Needleless Injection Site

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More Product Details

Catalog Number

D38301

Brand Name

AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber

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

K101958,K101958

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

82a95ffd-655c-42ae-bef8-89c02ef4e6a8

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

40704411004036

Quantity per Package

50

Contains DI Package

10704411004035

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