DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V - DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V - Intersurgical Incorporated

Duns Number:785952607

Device Description: DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V

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More Product Details

Catalog Number

-

Brand Name

DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V

Version/Model Number

2186000

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BSF

Product Code Name

Absorber, Carbon-Dioxide

Device Record Status

Public Device Record Key

82164312-a128-432a-b883-5f8d669941b9

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2021

Additional Identifiers

Package DI Number

05030267047086

Quantity per Package

10

Contains DI Package

05030267063710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101