N/A - GALEMED CORPORATION

Duns Number:656854379

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

Disposable Peep Valve 2.5cmH O, 22/19mm Pink

Brand Name

N/A

Version/Model Number

2471

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

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Device Record Status

Public Device Record Key

a19d2847-249d-4bd3-b8fa-2ed6861cc39c

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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