N/A - GALEMED CORPORATION

Duns Number:656854379

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More Product Details

Catalog Number

Wye Connector 22M

Brand Name

N/A

Version/Model Number

73041

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

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

1604f970-cf12-4a4c-94e4-241f3400ec2c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 15, 2015

Additional Identifiers

Package DI Number

44710810083264

Quantity per Package

4

Contains DI Package

24710810083260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"GALEMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 22