N/A - GALEMED CORPORATION

Duns Number:656854379

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More Product Details

Catalog Number

SF silicone hose 22F cuff, L= 35 cm

Brand Name

N/A

Version/Model Number

77022

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Device Record Status

Public Device Record Key

844ee736-8a5d-4833-9c0f-d58c5dc46de8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 15, 2015

Additional Identifiers

Package DI Number

44710810082380

Quantity per Package

60

Contains DI Package

04710810082382

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