Medline/MMS Sales - FILTER-ANESTHESIA, BULK - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: FILTER-ANESTHESIA, BULK

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More Product Details

Catalog Number

02-2001

Brand Name

Medline/MMS Sales

Version/Model Number

02-2001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K925217,K925217

Product Code Details

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Device Record Status

Public Device Record Key

444a1df5-2b68-495d-a02f-9f7df6dd4a8b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7