3000ML RECEPTAL™ CANISTER - 3000ML RECEPTAL™ CANISTER - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: 3000ML RECEPTAL™ CANISTER

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More Product Details

Catalog Number

435036118

Brand Name

3000ML RECEPTAL™ CANISTER

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

-

Prescription Use (Rx)

-

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

ab13cc3e-f357-4bc5-b543-6e65efe4f0f5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

40704411000984

Quantity per Package

8

Contains DI Package

00704411000986

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