Medline Industries, Inc. - RESUSCITATOR,MAN.INF,BAG,FILTER,PEEP - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: RESUSCITATOR,MAN.INF,BAG,FILTER,PEEP

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More Product Details

Catalog Number

CPRM3312FP

Brand Name

Medline Industries, Inc.

Version/Model Number

CPRM3312FP

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

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Device Record Status

Public Device Record Key

93960996-93b5-4db4-9199-e1a4fa02b0b1

Public Version Date

October 21, 2019

Public Version Number

4

DI Record Publish Date

October 09, 2015

Additional Identifiers

Package DI Number

40884389167855

Quantity per Package

12

Contains DI Package

10884389167854

Package Discontinue Date

-

Package Status

In Commercial Distribution

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