AMSure® Suction Connecting Tube - AMSure® Suction Connecting Tubew/o Male - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSure® Suction Connecting Tubew/o Male Connector, Non-Conductive

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More Product Details

Catalog Number

AS827BN

Brand Name

AMSure® Suction Connecting Tube

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Device Record Status

Public Device Record Key

39ee0691-6598-46c5-bfe4-b79a4e5956ae

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

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