Medline - REGULATOR,SUCTION,CONT,BARB,P-B,MRI - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: REGULATOR,SUCTION,CONT,BARB,P-B,MRI

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


More Product Details

Catalog Number

RTAC3BPBM

Brand Name

Medline

Version/Model Number

RTAC3BPBM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KDP

Product Code Name

REGULATOR, VACUUM

Device Record Status

Public Device Record Key

aa9a6120-e51c-471d-b431-b8d7d822d083

Public Version Date

November 25, 2021

Public Version Number

1

DI Record Publish Date

November 17, 2021

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