Medline Industries, Inc. - HP TBG 20IN ROT - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: HP TBG 20IN ROT

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More Product Details

Catalog Number

DYNJTBGHP20R

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJTBGHP20R

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

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

K071196,K071196

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

e65dcbbe-5388-4971-9b01-45c5e82ed0bf

Public Version Date

August 02, 2022

Public Version Number

7

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

40884389845227

Quantity per Package

50

Contains DI Package

10884389845226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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