AMSure® Universal Y connector 6-in-1 - AMSure® Universal Y connector 6-in-1CAUTION: - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSure® Universal Y connector 6-in-1CAUTION: Avoid freezing and excessive heat.

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More Product Details

Catalog Number

UYC001

Brand Name

AMSure® Universal Y connector 6-in-1

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

GCD

Product Code Name

Connector, Catheter

Device Record Status

Public Device Record Key

1d0c81c5-50e3-4c4e-b4b1-ecb565627bae

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

April 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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